12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Oticon
FDA UDI
Oticon A/S·05714464007233·OTICON MORE 1 MINIRITE R C094
BD BBL™ TCBS Agar
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902218729·BD BBL™ TCBS Agar
NeutrArt
FDA 510(k)
FDA Class 2
·General Hospital
PiezoImplant System
FDA 510(k)
FDA Class 2
·Dental
PLATE TCBS//TCBS 100 EA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSJ·September 16, 2021
PLATE TCBS//TCBS 100 EA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSJ·September 16, 2021
NEUROFORM 3 STENT SYSTEM
FDA Adverse Event
Injury
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code NJE·November 4, 2008
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·August 17, 2011
INFINITY SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 9, 2013
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025