11 results · 22ms · Sources: EU EUDAMED, US FDA

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GYN-1500 HYSTEROSCOPIC INUFFLATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Darby Dental Supply, LLC

FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813020494·GERM TRAY W/SS LD - WHITE DARBY

Stern IC 3.5 mm Drill

FDA UDI
STERNGOLD DENTAL LLC·00841549115134·A metal device used in dental surgery to create...

SwishPlant® Implant

FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307106029·5.7mmD x 6mmL, 6.5mmD Platform

LIGHT, HEAD, EXAMINATION

FDA 510(k)
FDA Class 1 ·General Hospital

MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013

COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 23, 2010

EASYTRAK 3

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code LWP·July 1, 2014

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

Alcon Custom Pak

FDA Enforcement
Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023