13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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JUVORA Dental Disc, Ceramill PEEK by JUVORA
FDA 510(k)
FDA Class 2
·Dental
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613154020676·Cruciate Retaining Tibial Insert
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 13, 2018
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 13, 2018
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 13, 2018
VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014
FDA 510(k)
FDA Unclassified
·Unknown
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 10, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·September 17, 2008