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1,523 catalysts · 4,728 grant · 3,603 8k filing · 2,587 approval · 1,915 device 510k · 1,523 device recall · 1,336 device pma
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1,523 catalysts · 4,728 grant · 3,603 8k filing · 2,587 approval · 1,915 device 510k · 1,523 device recall · 1,336 device pma
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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
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemosafeLock Connecter REF: KL-FNU3 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E. — Reason: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment. — Status: Ongoing
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Port REF: CL2100 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Bag Spike REF: CL-10 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing