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