15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ArthroFree Wireless Surgical Camera System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AUTO SUTURE SURGICAL STAPLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VISUAL-ICE CRYOABLATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMP RVS TRAY CO 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 7, 2019
ACCU-CHEK AVIVA
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·October 28, 2008
KENTROX SL 65/18
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·August 5, 2011
ALIGN TO URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·July 3, 2013
COMP LK SCR 3.5HEX 4.75X15 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 7, 2019
COMP LK SCR 3.5HEX 4.75X20 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 7, 2019
COMP LK SCR 3.5HEX 4.75X20 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 7, 2019
COMP PRIMARY STEM 14MM MINI
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·January 7, 2019
COMP RVS CNTRL 6.5X35MM ST/RST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 7, 2019
COMP RVRS SHLDR GLNSP STD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 7, 2019
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 7, 2019
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019