9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORZA XP Expandable Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
Mako
FDA UDI
MAKO SURGICAL CORP.·07613327395341·
Leonardo Mini Blue
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SANDHILL SCIENTIFIC PEDIATEC PH PROBE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 7, 2025
SIG MOD TIB TRAY CEM COCR 2
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 27, 2008
CURVE CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 17, 2011
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·July 3, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019