calendar
18,210 catalysts · 4,728 grant · 3,368 8k filing · 2,620 approval · 2,108 device 510k · 1,692 device recall · 1,464 device pma
next 91 dayslessmore
MonWedFri
18,210 catalysts · 4,728 grant · 3,368 8k filing · 2,620 approval · 2,108 device 510k · 1,692 device recall · 1,464 device pma
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
Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KGI. Advisory committee: Radiology. Type: Traditional
Product code: QYT. Advisory committee: Microbiology. Type: Traditional
Product code: DXT. Advisory committee: Cardiovascular. Type: Traditional
Product code: MJN. Advisory committee: Cardiovascular. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: LJT. Advisory committee: General Hospital. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Special
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: PNJ. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: SFA. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NPV. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NQA. Advisory committee: DE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: SFA. Advisory committee: OR. Decision: APPR
Supplement type: Special (Immediate Track). Product code: LYJ. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
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