11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GM85
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776184681·Hennig Plaster Spreader serrated outside blade
NA
FDA UDI
Smith & Nephew, Inc.·03596010103932·SUTURE WIRE 25 GA
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780381747·Integra® Jarit® Hennig Cast Spreader, 11"
TriVerse Femoral Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215097912·
URS-IG (GLUCOSE TEST)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIA-ROOT BIO Sealer
FDA 510(k)
FDA Class 2
·Dental
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 3, 2014
THERMOPHORE ARTHRITIS PAD
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·August 15, 2011
UNIFY CRT-D, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025