29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776084431·Somer Uterine Elevating Forceps
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193109237·HA PEEK EVOS Straight, ,10mmx8mmx 26mm , FLAT 5...
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0130100·Plate Holder
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0130100·Segmental Rod Reducer Assembly
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100100·Tray Insert
Navagio
FDA UDI
Kalitec Direct LLC·B07330K1100100·Tray Insert
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100100·Tray Insert 3, Cosmolock, Arcamed
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·April 12, 2018
LPS DISTAL FEM COMP XXSM LT
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 15, 2013
LAMITRODE S8
FDA Adverse Event
Injury
·ST JUDE MED - NEUROMODULATION·Product code GZB·September 17, 2014
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code MQR·August 17, 2017
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·March 12, 2015
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·March 15, 2018
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·February 19, 2014
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 12, 2014