13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CD Horizon Spinal System
FDA 510(k)
FDA Class 2
·Neurology
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022540·600 micron core/1040 micron OD Luer Lock Diode ...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111151590·SKLIT XD METZEN SCISS STR 7"
COOL TOUCH 3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTEGRA LICOX PTO2 MONITOR
FDA 510(k)
FDA Class 2
·Neurology
I-STAT CG8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·January 5, 2022
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 25, 2012
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 24, 2012
BD ARTERIAL CANNULA WITH FLOSWITCH
FDA Adverse Event
Injury
·BD·Product code DWF·March 17, 2015
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·November 10, 2008
ALLEGRATTO WAVE
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·August 26, 2011
VCARE
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code LKF·July 2, 2013
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014