11 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TELESCOPING PENEVAC (MODIFICATION)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
FDA 510(k)
FDA Class 2
·Orthopedic
COULTER LH 780 HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 5, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
C-QUR MESH
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code FTL·June 16, 2014
LC PCA NEW 802.11 AB
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·December 27, 2010
PROTÉGÉ ¿EVERFLEX¿ SELF EXPANDING BILIARY STENT SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code FGE·February 14, 2013
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 26, 2023
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026