11 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Craniomaxillofacial Distraction System (CMFD)
FDA 510(k)
FDA Class 2
·Dental
BI-METRIC HEAD/NECK HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304223189·
CRAWFORD LACRIMAL INTUBATION SET
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896018686·CRAWFORD LACRIMAL INTUBATION SET OLIVE PROBE SI...
IO-FLEX CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 11, 2013
KNEE IMPLANT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION·Product code JWH·July 14, 2011