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14,148 catalysts · 3,230 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
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14,148 catalysts · 3,230 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234; — Reason: The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model. — Status: Ongoing
Sponsor: ZYDUS LIFESCIENCES. Form: SUSPENSION. Route: ORAL
Sponsor: LEO PHARMA AS. Form: CREAM. Route: TOPICAL
Sponsor: AUROBINDO PHARMA. Form: SUSPENSION. Route: ORAL
Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: LEO PHARMA AS. Form: OINTMENT. Route: TOPICAL
Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL
Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: DR REDDYS. Form: CREAM. Route: TOPICAL
Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: OMP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional
Product code: GAM. Advisory committee: General, Plastic Surgery. Type: Special
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: SBF. Advisory committee: Neurology. Type: Traditional
Product code: QXW. Advisory committee: General, Plastic Surgery. Type: Direct
Product code: PDJ. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: PKC. Advisory committee: Orthopedic. Type: Traditional
Product code: ODG. Advisory committee: Gastroenterology, Urology. Type: Traditional
Supplement type: Normal 180 Day Track No User Fee. Product code: MNQ. Advisory committee: AN. Decision: APPR
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: SEG. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: OWD. Advisory committee: MG. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: EZY. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo — Reason: As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout. — Status: Ongoing
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F. — Reason: Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals. — Status: Ongoing
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; — Reason: It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy. — Status: Ongoing
Sponsor: ARCUTIS. Form: CREAM. Route: TOPICAL
Supplement type: Normal 180 Day Track No User Fee. Product code: NPU. Advisory committee: CV. Decision: APPR
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS. Form: TABLET. Route: ORAL
Sponsor: ALKEM LABS LTD. Form: PATCH. Route: TOPICAL