30 results · 21ms · Sources: EU EUDAMED, US FDA

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CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SEXTANT SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009

AirLife™

FDA UDI
AIRLIFE·10889483569559·AirLife™ Adult Dual Dial Venturi Style Mask Wit...

AirLife™

FDA UDI
VYAIRE MEDICAL, INC.·10190752116504·AirLife™ Adult Dual Dial Venturi Style Mask Wit...

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001255·artVeneer life lower anteriors, UBL, B3

OptiLIF Endo, Direct Visualization System

FDA UDI
SPINEOLOGY INC.·M7401001255·TF Endo Head

LIFEPAK® 15 monitor/defibrillator

FDA UDI
PHYSIO-CONTROL, INC.·00883873911648·15AABBABBABBBAAAAAAAAAABLP15 MONITOR/DEFIB

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361008446·PedFuse Respond, CNL, 6.0mm x 55mm

N/A

FDA UDI
Doppkon GmbH & Co. KG·04262494462849·Cannulated Tibial Reamer D 10.5mm, WL 180mm

COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODEL 4300 PSARRAY EEG ELECTRODE SET

FDA 510(k)
FDA Class 2 ·Neurology

HNM Medical

FDA UDI
HNM STAINLESS, LLC.·00842962156308·HIP ARTHROSCOPE SHEATH, W/2 STOPCOCK, 5.5MM, BL...

0009613348-2026-001255

FDA Adverse Event
Injury ·INSTITUT STRAUMANN AG·Product code DZE·January 23, 2026

CARE-FUSION

FDA Adverse Event
Other ·CAREFUSION RESPIRATORY CARE·Product code BYF·June 24, 2010

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code PQF·April 14, 2018

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·February 24, 2011

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 22, 2008

LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602

FDA Recall
Open, Classified ·Physio-Control, Inc.·Product code MKJ·September 29, 2023

LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602

FDA Enforcement
Class II ·Ongoing·Physio-Control, Inc.·November 22, 2023