calendar
2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,387 8k filing · 2,000 device pma
next 91 dayslessmore
MonWedFri
2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,387 8k filing · 2,000 device pma
no tagged catalysts yet
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic — Reason: The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results. — Status: Ongoing
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic — Reason: The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results. — Status: Ongoing
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only. — Reason: Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results. — Status: Ongoing
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing
Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing
Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224 — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits IHDC30R D AND C PACK — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Basic Biopsy Tray, Item Number NMBP44L — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IASH65A SHOULDER PACK IHUE40AI UPPER EXTREMITY PK| STRL F G ILTJ47AA TOTAL JOINT PACK LMHP14Z ORIF HIP, ST LUKES METHODIS LMSN44AE SPINAL PACK MHHP25H HAND PACK - 206002 MHTH90AJ TOTAL HIP PACK - 206016 MWAH32P ANTERIOR HIP PACK MWTK13AH TOTAL KNEE PLOR89H ORTHO MINOR PACK RCUE81B UPPER EXTREMITY RCH 0247031 TSTH54D TOTAL HIP TRAY UDEX85Y DSC EXTREMITY - 206050 UDHD69U HAND PACK - 206055 UDKN68AH CUSTOM KNEE - 206061 UIHN18AW ACS HAND PACK (PS 020640) UIHN18AX ACS HAND PACK (PS 020640) UIKN28AR ASC KNEE PACK (PS 020641) UISO44I SFCH SMALL ORTHO PACK (PS 143213) — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PACK - 206005, MHRB88AO ROBOTIC PACK - 242561, RCLC51C LAP CHOLE RCH 0246969, SMLC53C LAP CHOLE PACK, UDLC17AE DSC LAP CHOLE PACK - 206062, UIRU84AE ROBOTIC UROLOGY PACK (PS 060571) — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209 — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573) — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
XERF EFFECTOR 60. Electrosurgical unit. — Reason: Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients. — Status: Ongoing
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419) — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC DRAPE PACK (PS 907284) UIVA75I VASCULAR PACK — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40 — Reason: Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device. — Status: Ongoing
Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL (PS 64405) UISH15AV SHUNT PACK (PS 039360) — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951 — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634) — Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. — Status: Ongoing
Philips S5-2 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 — Reason: Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data. — Status: Ongoing
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube — Reason: GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120. — Status: Ongoing
Philips S4-1 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component — Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. — Status: Ongoing
Philips X3-1 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Philips OMNI II TEE Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393 — Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use. — Status: Ongoing
Philips L17-5 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube — Reason: GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120. — Status: Ongoing
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393 — Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use. — Status: Ongoing
Philips Mini Multi TEE Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Philips OMNI III TEE Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393 — Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use. — Status: Ongoing
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component — Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. — Status: Ongoing
Philips 3D6-2 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Philips X7-2 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Philips C9-4 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Philips L12-5 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component — Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. — Status: Ongoing
Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE, FREDX5522-PMA, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA, MV-F352427X — Reason: Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences. — Status: Ongoing
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy. — Reason: Potential for compromised integrity of the sterile packaging. — Status: Ongoing
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials to reinforce and maintain the cleft. — Reason: Potential for compromised integrity of the sterile packaging. — Status: Ongoing