12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROZYME T3 ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ERA Implant Abutment Std Ang Base, 2mm Cuff (AE)
FDA UDI
STERNGOLD DENTAL LLC·00841549113888·ERA abutments provide a resilient attachment wi...
Swish™ Straight Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307116547·
Swish™ Straight Solid Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307116561·
THERA-CANE
FDA 510(k)
FDA Class 1
·Physical Medicine
MEMORYMATE HEARING AID WITH PMC PROGRAMMER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 14, 2026
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 9, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 22, 2010
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·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
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021