26 results · 31ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ECVUE Mapping System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Oticon

FDA UDI
Oticon A/S·05707131282569·H11V2, BTE 13 WL 85 CBE

REMREST HEATED HUMIDIFIER

FDA 510(k)
FDA Class 2 ·Anesthesiology

GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ELECSYS FREE PSA IMMUNOASSAY

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code MTG·March 3, 2017

S3 ROLLER PUMP

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)·Product code DTQ·April 23, 2010

STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·July 13, 2021

3 TO 1 REDUCTION DRIVE

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 14, 2011

S3 ROLLER PUMP MODULE AND CONSOLE

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR·Product code DTQ·March 24, 2010

3-TO-1 REDUCTION DRIVE

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHMAND·Product code DTQ·December 14, 2011

STOCKERT S3 CONSOLE

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011

STOCKERT S3 CONSOLE

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
MEDEL S.P.A.·Product code BTI·June 6, 2013

IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

FDA Adverse Event
Malfunction ·X-SPINE SYSTEMS, INC.·Product code OVE·October 8, 2014

UNKNOWN DEPUY HIP HEAD

FDA Adverse Event
Injury ·DEPUY INTL. LTD.·Product code KWY·June 29, 2011

OPTETRAK LOGIC

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·March 27, 2023

SENSOR, LOW LEVEL II

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·April 16, 2010

S3 ROLLER PUMP

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)·Product code DTQ·April 23, 2010

S3 ROLLER PUMP

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·April 22, 2010

S3 ROLLER PUMP

FDA Adverse Event
SORIN GROUP DEUTSCHLAND·Product code DWB·October 12, 2016