9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112946·CORNEAL TREPHINE BLADE8.25MM
BEAUTICEM SA
FDA 510(k)
FDA Class 2
·Dental
SMITH & NEPHEW TWINFIX TI QUICK T
FDA 510(k)
FDA Class 2
·Orthopedic
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 3, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 23, 2011
UNIFY QUADRA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LPH·October 17, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025