9 results
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28ms
·
Sources: EU EUDAMED, US FDA
LAP 3501 HIGH FLOW INSUFFLATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Stern IC 2.8 mm Drill
FDA UDI
STERNGOLD DENTAL LLC·00841549115127·A metal device used in dental surgery to create...
CUSTOMED CYSTO PACK II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
RF MULTIGEN
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GXD·November 12, 2010
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code KRG·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