14 results · 20ms · 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.

ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ARGELOY NP SUPREME 100g

FDA UDI
ARGEN CORPORATION, THE·D818112738·Base metal alloy

OTHER EXTERNAL FIXATION

FDA UDI
Smith & Nephew, Inc.·03596010042507·HEX-FIX ADD-A-CLAMP

LANX FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SYMPHONY GRAFT DELIVERY SYSTEM (GDS)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

PASS LP - LIGAPASS

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code JDQ·April 26, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

PURITAN BENNETT 980 SERIES VENTILATOR

FDA Adverse Event
Malfunction ·MEDTRONIC/COVIDIEN·Product code CBK·September 17, 2025

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code BTI·May 14, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

HERCULES 3 STAGE BALLOON ESOPHAGEAL

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNQ·May 27, 2011

PASS LP - LIAPASS

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025