18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
FDA 510(k)
FDA Class 2
·Radiology
ECHO BI-METRIC MICROPLASTY HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304697843·
CETRA
FDA UDI
Orthofix US LLC·18257200123186·4.0MM X 17MM PRIMARY CONSTRAINED SELF-TAPPING S...
STELLAR 300
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Versa-Fx®
FDA UDI
Zimmer, Inc.·00889024036406·
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 16, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 13, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 27, 2013
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 21, 2011
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 9, 2013
SROM*STM ST,36+8L NK,18X13X160
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 9, 2013
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 8, 2013
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 8, 2013
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 8, 2013
SROM*STM ST,36+8L NK,18X13X160
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 8, 2013
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021