11 results
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25ms
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Sources: EU EUDAMED, US FDA
POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880206180·dentaform® Snap Band, Tooth 46, Size 6/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880206000·dentaform® Snap Band, Tooth 46, Size 6
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880206220·dentaform® Snap Band, Tooth 46, Size 6/Roth 22
NA
FDA UDI
STRYKER CORPORATION·07613327060393·Albarran Bridge, Single Horn
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
neuromate Gen III
FDA 510(k)
FDA Class 2
·Neurology
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·December 19, 2012
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·October 15, 2010
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·January 13, 2014
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025