15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESUSCI PATIENT FACE SHIELD
FDA 510(k)
FDA Class 2
·Anesthesiology
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799008374·
UniTip Catheter
FDA UDI
Unisensor AG·07640172973776·
Corvocet Biopsy System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STRYKER POWER TOOL NAVIGATOR ATTACHMENT
FDA 510(k)
FDA Class 2
·Neurology
ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE
FDA Adverse Event
Malfunction
·SHERWOOD DAVIS AND GECK·Product code KNT·August 29, 1996
ATLAS II PLUS DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code FKX·October 22, 2010
MEGASUTURECUT NEEDLE DRIVER
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 19, 2012
G7 FINNED 4 HOLE SHELL 60G
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code LPH·July 27, 2023
36MM COCR MOD HD +3MM
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JDI·July 27, 2023
TI LOW PROFILE SCREW 6.5X35MM
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code KWA·July 27, 2023
G7 HI-WALL E1 LINER 36MM G
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code PBI·June 21, 2023
ARCOS 15X190MM SPL TPR DIST
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code KWA·June 21, 2023
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025