13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517631046·CoRoent Ant TLIF Ti, 14x10x28mm 12°
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017965·K-Wire, Single Ended, Trocar Point, Diameter Si...
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00643169483446·SHUNT 24028-2 DELTA ASY REG SNAP PER 2.0
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00613994908421·SHUNT 24028-2 DELTA ASY REG SNAP PER 2.0
ST SENSE NV 8 ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 7, 2024
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 10, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 8, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013