11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
FDA 510(k)
FDA Class 2
·Immunology
Armada
FDA UDI
Nuvasive, Inc.·00887517234841·Armada Ti 3CO Osteotome, 12mm Lum
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
PELIMIT
FDA 510(k)
FDA Class 2
·Physical Medicine
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
FDA 510(k)
FDA Class 1
·General Hospital
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 7, 2013
CONCERTO II CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·February 15, 2011
PROTECTA CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021