12 results
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18ms
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Sources: EU EUDAMED, US FDA
TOTAL CHOLESTEROL REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Endodontic Hand Instruments
FDA UDI
TULSA DENTAL PRODUCTS LLC·D71668550281·HEDSTROM READY STEEL 31MM 45-80
ReadySteal Hedstrom File
FDA UDI
TULSA DENTAL PRODUCTS LLC·D71668550282·Ready Steal Hedstrom File Size 6855028 Length
PowerBar
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746164927·FIXED FUNCT POWERBAR CLASS II 28MM UNIV 2/PK
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209137152·
MARTANIQUE 7-TUBE RUVA HOME SOLARIUM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 9, 2014
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 5, 2010
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 3, 2012
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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
PM 1260 ASSURITY + 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