34 results · 19ms · Sources: EU EUDAMED, US FDA

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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