18 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Revitive Medic Plus, Revitive Advanced 2
FDA 510(k)
FDA Class 2
·Physical Medicine
BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
FDA 510(k)
FDA Class 2
·Orthopedic
DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·September 15, 2021
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·March 1, 2022
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·August 1, 2022
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008
TRUSAT POWER SUPPLY
FDA Adverse Event
Malfunction
·CRITIKON DE MEXICO S. DE R.L. DE C.V.·Product code DPZ·July 19, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 26, 2013
EARLYVUE VS30 VITALS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSJ·June 14, 2021
EARLYVUE VS30 VITALS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2021
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
BD MICROLANCE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·October 7, 2022
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Alinity i TSH Reagent Kit, List Number 07P4830
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020