11 results
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26ms
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Sources: EU EUDAMED, US FDA
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
ComposiTCP
FDA UDI
S.B.M·03760154007160·Absorbable interference screw
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221113184·3M™ Victory Series™ Second Molar Bands, 905-211...
SKYTRON UNIVERSE SERIES SURGICAL LIGHTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGILASE SL50 SURGICAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
OMNILINK .035 STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA·Product code FGE·November 22, 2010
M2A MAGNUM TPR ADPR TI DIA42-50/+3MM(T1)
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·July 1, 2014
Various convenience packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·May 13, 2020
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·May 13, 2020