10 results
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30ms
·
Sources: EU EUDAMED, US FDA
BIODEX,MODEL B-2000
FDA 510(k)
FDA Class 2
·Physical Medicine
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052022280·Handpiece, manual operation
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540355331·INSTRUMENT TRAY F. MANDIB. RECON INSTR.
LIGHTLANCE LASER SKIN PERFORATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
METRX SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 14, 2014
PROSIMA PELVIC FLOOR REPAIR KIT
FDA Adverse Event
Injury
·ETHICON, INC·Product code FTL·January 14, 2013
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 18, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024