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20,672 catalysts · 4,728 grant · 3,382 8k filing · 3,243 device 510k · 2,824 approval · 2,000 device pma · 2,000 device recall
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20,672 catalysts · 4,728 grant · 3,382 8k filing · 3,243 device 510k · 2,824 approval · 2,000 device pma · 2,000 device recall
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 — Reason: The catheters may not retain their shape. — Status: Ongoing
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KWL. Advisory committee: Orthopedic. Type: Special
Product code: DPS. Advisory committee: Cardiovascular. Type: Traditional
Product code: JXG. Advisory committee: Neurology. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Abbreviated
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: NRA. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKT. Advisory committee: MI. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NRA. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
FloPatch FP120, REF: FP120-FOT01-005 — Reason: Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20. — Status: Ongoing
Product code: QPL. Advisory committee: Neurology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GXD. Advisory committee: Neurology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: QEB. Advisory committee: Anesthesiology. Type: Traditional
Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS
Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS
Supplement type: 30-Day Notice. Product code: NIU. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NXW. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: OZD. Advisory committee: CV. Decision: APPR
Product code: MNQ. Advisory committee: AN. Decision: APPR
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: PNK. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: PQP. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set — Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation. — Status: Ongoing
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Software Version: 12.0.4.12. 5. RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119. Product Description: Radiation Therapy Treatment Planning System. — Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. — Status: Ongoing