34 results
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19ms
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Sources: EU EUDAMED, US FDA
LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706
FDA 510(k)
FDA Class 1
·Anesthesiology
Endeavour™ MD
FDA UDI
METREX RESEARCH, LLC·00615375013960·Endeavour™ MD headlight system - North America,...
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
FDA 510(k)
FDA Class 2
·Cardiovascular
NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
COYOTE¿ ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·May 9, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011
PRECISE OTW NITINOL STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·August 5, 2008
UNKNOWN KNEE CONSTRUCT ATTUNE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 19, 2025
UNK ATTUNE KNEE PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 19, 2025
UNK ATTUNE FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 19, 2025
GALAXY G3 MINI 2.5MM X 5.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·August 2, 2021
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016