20 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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Stern Fix Sternal Stabilization System
FDA 510(k)
FDA Class 2
·Orthopedic
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383514842·"An absorbent paper points is an endodontic pap...
Ti Pro-Link Stand-Alone Cervical System
FDA UDI
Life Spine, Inc.·00190837017668·
Pro-Link Stand-Alone Cervical Spacer System
FDA UDI
Life Spine, Inc.·00190837013738·
Ti Pro-Link Stand-Alone Cervical System
FDA UDI
Life Spine, Inc.·00190837017651·
Pro-Link Stand-Alone Cervical Spacer System
FDA UDI
Life Spine, Inc.·00190837013721·
Pro-Link Stand-Alone Cervical Spacer System
FDA UDI
Life Spine, Inc.·00190837013707·
Pro-Link Stand-Alone Cervical Spacer System
FDA UDI
Life Spine, Inc.·00190837013714·
Ti Pro-Link Stand-Alone Cervical System
FDA UDI
Life Spine, Inc.·00190837017682·
Ti Pro-Link Stand-Alone Cervical System
FDA UDI
Life Spine, Inc.·00190837017675·
POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
XELIS FUSION
FDA 510(k)
FDA Class 2
·Radiology
ICY® JAPAN, INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN CUSTOM LUER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code NCX·October 2, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014
ALTRUA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 8, 2013
LAMITRODE S-8 LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 9, 2015
BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
FDA Enforcement
Class II
·Terminated·Tenex Health Inc·May 14, 2014
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020