525 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193104409·HA PEEK EVOS Curved, , 12mmx9mmx 26mm , BICONVE...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0120120·Screwdriver, NIDO Assembled Screws, Sleeved
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0120120·Screwdriver, Polyaxial, Standard
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ECG HOME
FDA 510(k)
FDA Class 2
·Cardiovascular
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 9, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 4, 2012
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH. LTD./HUNTINGTON·Product code HQL·March 28, 2012
NEXGEN STEMMED TIBIAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·July 12, 2013
PROVENTIL HFA 6.7G - 200 METERED INHALATIONS
FDA Adverse Event
Malfunction
·SCHERING CORP., A SUBSIDIARY OF SCHERING PLOUGH·Product code KCO·November 10, 2010
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 24, 2012
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 16, 2013
BD FACSDIVA VERSION 6.0 AND 6.1
FDA Adverse Event
Malfunction
·BD BIOSCIENCES·Product code GKZ·June 13, 2008
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 6, 2011
UNITRAX MODULAR ENDO HEAD 54MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code KWL·August 21, 2012
PROAIR HFA (90 MCG)
FDA Adverse Event
Malfunction
·IVAX WATERFORD, IRELAND FOR TEVA RESPIRATORY LLC·Product code CCQ·September 11, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 27, 2012
SPINBRUSH¿ PROCLEAN¿ POWERED TOOTHBRUSH
FDA Adverse Event
Malfunction
·CHURCH & DWIGHT CO., INC.·Product code JEQ·March 29, 2013