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18,288 catalysts · 4,728 grant · 3,153 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
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18,288 catalysts · 4,728 grant · 3,153 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Special
Product code: SFO. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: BWF. Advisory committee: Anesthesiology. Type: Traditional
Sponsor: SOBI. Form: CAPSULE. Route: ORAL
Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS
Supplement type: 135 Review Track For 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: OSR. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: KGG. Advisory committee: NE. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NIM. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: QQK. Advisory committee: GU. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: APPR
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. — Reason: One lot manufactured with an invalid sterilization cycle. — Status: Ongoing
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4 — Reason: If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use. — Status: Ongoing
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. — Reason: One lot manufactured with an invalid sterilization cycle. — Status: Ongoing
Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures. Component: N/A — Reason: Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping. — Status: Ongoing
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. — Reason: One lot manufactured with an invalid sterilization cycle. — Status: Ongoing
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: EKX. Advisory committee: Dental. Type: Traditional
Product code: KRO. Advisory committee: Orthopedic. Type: Special
Product code: NRY. Advisory committee: Cardiovascular. Type: Special
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Product code: DQY. Advisory committee: Cardiovascular. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: KIF. Advisory committee: Dental. Type: Special
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Supplement type: Normal 180 Day Track No User Fee. Product code: MAQ. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MFK. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis. — Reason: Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. — Status: Ongoing
Product code: QAI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QFR. Advisory committee: Hematology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: PZR. Advisory committee: Neurology. Type: Traditional