10 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cleerly LABS (v2.0)
FDA 510(k)
FDA Class 2
·Radiology
DEPUY SYNTHES
FDA UDI
Medos International Sàrl·10886705028191·LID FOR DEPUY SYNTHES VISUALIZATION RECTANGULAR...
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272423381·Buser Elevator Periosteal ARTMAN
THERAPY ABLATION CATHETER
FDA Adverse Event
Malfunction
·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code OAD·June 25, 2010
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)
FDA 510(k)
FDA Class 2
·Microbiology
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·November 21, 2008
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 10, 2011
SMALL PERIPHERAL CUTTING BALLOON®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025