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12,383 catalysts · 3,603 8k filing · 2,369 grant · 1,782 approval · 1,176 device 510k · 1,000 device adverse event · 851 device pma
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12,383 catalysts · 3,603 8k filing · 2,369 grant · 1,782 approval · 1,176 device 510k · 1,000 device adverse event · 851 device pma
Sponsor: MIKART. Form: SOLUTION. Route: ORAL
Sponsor: GENUS LIFESCIENCES. Form: SOLUTION. Route: ORAL
Sponsor: GENUS LIFESCIENCES. Form: SOLUTION. Route: ORAL
Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL
Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: FZP. Advisory committee: General, Plastic Surgery. Type: Special
Product code: FZP. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: DRN. Advisory committee: Cardiovascular. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: LEL. Advisory committee: Neurology. Type: Traditional
Product code: OVE. Advisory committee: Orthopedic. Type: Special
Product code: FMF. Advisory committee: General Hospital. Type: Special
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: GAM. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HTN. Advisory committee: Orthopedic. Type: Special
Product code: MMK. Advisory committee: General Hospital. Type: Traditional
Product code: DPS. Advisory committee: Cardiovascular. Type: Traditional
Product code: PKP. Advisory committee: General Hospital. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DTN. Advisory committee: Cardiovascular. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Product code: NPU. 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: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: PRL. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit — Reason: BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators. — Status: Ongoing
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710FJ282CRH; — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing