9 results
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35ms
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Sources: EU EUDAMED, US FDA
EASY EYES TM CONTACT LENS CLEANING MACHINE
FDA 510(k)
FDA Class 2
·Ophthalmic
ERA Implant Abutment Std 0 Deg, 3mm Cuff (AE)
FDA UDI
STERNGOLD DENTAL LLC·00841549113925·ERA abutments provide a resilient attachment wi...
FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)
FDA 510(k)
FDA Class 1
·Dental
EXTENDED CHIN IMPLANT STYLE I
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 9, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 22, 2010
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2014
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015