22 results · 20ms · Sources: EU EUDAMED, US FDA

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ELASTIC IMPRESSION MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SYNTHECEL DURA REPLACEMENT DEVICES

FDA 510(k)
FDA Class 2 ·Neurology

BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA

FDA Adverse Event
Injury ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 8, 2022

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 29, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 18, 2011

PSI KIT: 8.5 FR

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DYB·August 22, 2008

EVIS LUCERA ELITE COLONOVIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDF·November 12, 2024

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code JDS·July 25, 2016

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code JDS·July 25, 2016

BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 14, 2022

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

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 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