10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
COMPUTER, CARDIAC OUTPUT (#SP1425)
FDA 510(k)
FDA Class 2
·Cardiovascular
Ceramill Splintec
FDA UDI
Merz Dental GmbH·D709760532·Ceramill Splintec 98x14 N/US
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110652·COAXIAL IRR-ASP TIP 45 DEG W/ SILICONE
Greiner Holdex
FDA 510(k)
FDA Class 2
·General Hospital
HDR 1000 PLUS WELL CHAMBER, MODEL 90008
FDA 510(k)
FDA Class 2
·Radiology
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·September 26, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 19, 2013
DIST TIB ANTLAT RIGHT BROAD 6H
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HRS·July 15, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025