10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SILHOUETTE, SUNLIMETED,ADIDAS
FDA 510(k)
FDA Class 1
·Ophthalmic
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704267358·
VENTIBOX
FDA 510(k)
FDA Class 1
·Radiology
CYTOSMEAR BRUSH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·January 25, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER- SILICON VALLEY·Product code GEX·December 29, 2010
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 7, 2014
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code OVE·April 8, 2015
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015