30 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295243373·P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZ...
Sklar Instruments
FDA UDI
SKLAR CORPORATION·10649111068966·ECONO STERILE PEDERSON SPEC STERILE SM BX/25
ELITE
FDA UDI
DEPUY INTERNATIONAL LTD·10603295243380·ELITE SOCKET GAUGE FOR 53MM CUP
Integrated Catch-up Freedom Syringe Driver Infusion System
FDA 510(k)
FDA Class 2
·General Hospital
BIS EEG MONITOR VIEW
FDA 510(k)
FDA Class 2
·Neurology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·June 18, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 14, 2013
CAREFUSION
FDA Adverse Event
Malfunction
·CAREFUSION/CARDINAL·Product code FRN·January 11, 2011
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615; 6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616; 7) ECONO STERILE PEDERSON SPEC STRL LG BX/25, Model Number 96-2617; 8) ECONO STERILE GRAVES VAG SPEC STRL MD CS/50, Model Number 96-3001; 9) ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, Model Number 96-3002; speculum, gynecological
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
DRILL BIT Ø1.5 W/STOP L44.5/12 2FLUTE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTW·January 31, 2013
2.0MM DRILL BIT/QC/100MM
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HTW·March 26, 2013
3.0MM TI CANNULATED SCREW LONG THREAD/32MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·June 12, 2014
3.0MM TI CANNULATED SCREW SHORT THREAD/32MM
FDA Adverse Event
Malfunction
·SYNTHE USA·Product code HWC·June 12, 2014
1.1MM THREADED GUIDE WIRE 150MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code FZX·June 12, 2014
1.1MM THREADED GUIDE WIRE 150MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code FZX·June 12, 2014
1.1MM THREADED GUIDE WIRE 150MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code FZX·June 12, 2014
1.1MM THREADED GUIDE WIRE 150MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code FZX·June 12, 2014
3.0MM TI CANNULATED SCREW SHORT THREAD/20MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·June 12, 2014
1.1MM THREADED GUIDE WIRE 150MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code FZX·June 12, 2014