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18,221 catalysts · 4,728 grant · 3,147 8k filing · 2,634 approval · 2,175 device 510k · 1,759 device recall · 1,520 device pma
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18,221 catalysts · 4,728 grant · 3,147 8k filing · 2,634 approval · 2,175 device 510k · 1,759 device recall · 1,520 device pma
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
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: GWN. Advisory committee: Neurology. Type: Traditional
Product code: EBW. Advisory committee: Dental. Type: Traditional
Product code: GGP. Advisory committee: Hematology. Type: Traditional
Product code: KWY. Advisory committee: Orthopedic. Type: Traditional
Sponsor: HORIZON THERAPEUTICS IRELAND. Form: INJECTABLE. Route: INJECTION
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. — Reason: Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing. — Status: Ongoing
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS. — Reason: Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing. — Status: Ongoing