11 results
·
23ms
·
Sources: EU EUDAMED, US FDA
MOD 482
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517159687·CoRoent® XLF, 8x18x50mm 10°
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·December 18, 2014
STYLE 10 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·October 16, 2020
Alma Q
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE
FDA Adverse Event
Malfunction
·SHERWOOD DAVIS AND GECK·Product code KNT·August 29, 1996
1.1MM NON-THREADED GUIDE WIRE 150MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code FZX·June 12, 2014
LAMITRODE TRIPOLE 16 LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 7, 2010
HARMONIC ACE CURVED SHEARS INSERT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 12, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020