13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLATEAU SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213036260·Coupling Treatment Tube for 6F Flexibles (22)
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOSORBFX O/M 2.0/2/4 SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 13, 2024
ATTUNE PS FB INSRT SZ 4 10MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 121965·Product code JWH·November 25, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 14, 2013
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 13, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·August 13, 2008
MISSION KIT
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·August 7, 2025
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025