17 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUNIVF DISHES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LEONE SPA
FDA UDI
LEONE SPA·08033707001072·MEDIUM SCREWS S/STEEL 11mm
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606057·SKYTRON 3501 B STANDARD 2" POLYFOAM W/LECTROLIT...
E-POWER
FDA 510(k)
FDA Class 2
·Physical Medicine
EINSTEIN PROCESSING AND REVIEW WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
REAMER SHAFT, MOD. TRINKLE BIXCUT 8.0 X 284 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 18, 2012
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·March 25, 2015
REBOUND HRD
FDA Adverse Event
Malfunction
·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011
7.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LGTH
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·April 26, 2013
LAMITRODE S-8 LEAD, 60CM LENGTH
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 22, 2011
WALLFLEX ENTERAL COLONIC STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MQR·July 22, 2008
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·March 12, 2015
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·November 12, 2014
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code ESW·November 27, 2014
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code ESW·November 24, 2014
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015