12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
INMODE WMBODY DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bernafon
FDA UDI
Bernafon AG·05711584049419·PC9 NR, PS MAC PRECISO 9
BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·August 5, 2022
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STELO GLUCOSE BIOSENSOR SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code SAF·May 28, 2025
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 1, 2014
PELVICOL ACELLAR COLLAGEN MATRIX 4X7CM
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·May 20, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011
BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·August 10, 2022
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
FDA Enforcement
Class I
·Ongoing·Abbott Vascular·May 25, 2022