11 results · 19ms · Sources: EU EUDAMED, US FDA

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DISPOSABLE PROPHYLAXIS ANGLE

FDA 510(k)
FDA Class 1 ·Dental

P.F.C. SIGMA

FDA UDI
DEPUY (IRELAND)·10603295230267·P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM RP...

Elite® Buccal Tubes Direct Bond

FDA UDI
Ortho Organizers, Inc.·00190707074425·Elite®.018 EDGE L7L MINI HK DB

MectaLIF 3D Metal

FDA 510(k)
FDA Class 2 ·Orthopedic

PASSY-MUIR TRACH VALVE

FDA 510(k)
FDA Class 2 ·Anesthesiology

COULTER® ACT DIFF 2 ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC·Product code GKZ·December 7, 2010

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 8, 2013

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·January 6, 2011

G7 SCREW 6.5MM X 30MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JDI·July 22, 2014

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017