14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IFUSION
FDA 510(k)
FDA Class 2
·Ophthalmic
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975057044·
LINK Instruments - Impactors, extractors and insertion
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575033232·Orthopaedic prosthesis instrument, reusable - G...
devemed
FDA UDI
devemed GmbH·04061644022120·Enamel chisel "Wedelstaedt" # 5-6
for refine th...
ENVAN HEART RATE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)
FDA 510(k)
FDA Class 2
·Physical Medicine
Reicodent
FDA UDI
devemed GmbH·04061644027798·Enamel chisel "Wedelstaedt" # 5-6
for refine th...
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016
ASPHERE M SPEC 12/14 36 +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code JDI·May 24, 2013
UNIDENTIFIED ASR HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·September 30, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
TIBIAL INSERT FB SZ 1 LT 6MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·August 31, 2023
AVAN REINF RING SS 48/58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019