12 results
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25ms
·
Sources: EU EUDAMED, US FDA
GLUCOSE HEXOKINASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880236000·dentaform® Snap Band, Tooth 46, Size 36
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880236220·dentaform® Snap Band, Tooth 46, Size 36/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880236180·dentaform® Snap Band, Tooth 46, Size 36/Roth 18
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ABCO MERCURIAL SPHYGMOMANOMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
START-X TIP EMS INSERT 5
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code ELC·August 28, 2025
METRX
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·June 18, 2014
NONE
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code LYC·October 19, 2010
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 19, 2012
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
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020