8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INVAC W/VARIOUS MODELS
FDA 510(k)
FDA Class 2
·General Hospital
LEONE SPA
FDA UDI
LEONE SPA·08033707096153·DB TUBE MIM LOW PROFILE 22 T-14R+8 UR
VECTRA (INTELECT) EPR ULTRASOUND
FDA 510(k)
FDA Class 2
·Physical Medicine
U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER
FDA 510(k)
FDA Class 2
·Orthopedic
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 23, 2014
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012
CURRENT PLUS DR, SJ4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015