25 results · 25ms · 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.

NUVASIVE COROENT EXTENSURE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NUVASIVE

FDA Adverse Event
Injury ·NUVASIVE·Product code NKB·January 10, 2011

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809849493·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE LARGE FU...

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690192152·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0122100·T-Handle, Head Persuader

SYNTRA DIALYZER, MODEL SYNTRA 120, 160

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO ACCU-CHEK INFORM METER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SLEEPEASY

FDA Adverse Event
Injury ·RESPIRONICS INC.·Product code BZD·April 12, 2012

REMSTAR PLUS M-SERIES

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code BZD·May 6, 2010

REMSTAR M SERIES

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code BZD·November 25, 2009

M-SERIES DC POWER SUPPLY

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·May 25, 2012

PROMUS ELEMENT¿ PLUS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 11, 2013

UNKNOWN BONE MORPHOGENETIC PROTEIN

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code NEK·April 12, 2011

LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·May 21, 2008

BASEPLATE IMPACTOR, ASSEMBLY

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code LXH·June 11, 2024

BASEPLATE IMPACTOR, ASSEMBLY

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code LXH·June 11, 2024

BASEPLATE IMPACTOR, ASSEMBLY

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code LXH·June 11, 2024

OUTRIGGER TARGETING GUIDE

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code LXH·March 21, 2025

REMSTAR PLUS M-SERIES

FDA Adverse Event
Death ·RESPIRONICS, INC.·Product code BZD·March 16, 2012

REMSTAR M SERIES

FDA Adverse Event
Malfunction ·RESPIRONICS INC·Product code BZD·February 24, 2010