14 results
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21ms
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Sources: EU EUDAMED, US FDA
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017965·K-Wire, Single Ended, Trocar Point, Diameter Si...
Phantom
FDA UDI
Innovative Med·00851314007038·Surgical Aspirator:1/3 hp. 0-3.6 scfm / 0-27.5 ...
S-ROM*SLEEVE PRX ZTT, 18B-SML
FDA Adverse Event
Injury
·9616671 DEPUY IRELAND·Product code LPH·October 10, 2013
S-ROM M 28MM HEAD +6
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·October 10, 2013
PINNACLE SECTOR II CUP 48MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC·Product code KWA·October 10, 2013
SROM*STM ST,30+4L NK,18X13X160
FDA Adverse Event
Injury
·9616671 DEPUY IRELAND·Product code JDI·October 10, 2013
ULTAMET MTL INS NEUT 28MM 48OD
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code KWA·October 10, 2013
MICOR Lens Fragmentation System
FDA 510(k)
FDA Class 2
·Ophthalmic
COPAL® exchange G hip spacer; COPAL® G+V
FDA 510(k)
FDA Class 2
·Orthopedic
VITALITY DS
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
HOMECHOICE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 19, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 30, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025