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17,754 catalysts · 4,728 grant · 3,086 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
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17,754 catalysts · 4,728 grant · 3,086 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
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
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. — 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
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use. — Reason: Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section. — Status: Ongoing
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional