10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
artegral
FDA UDI
Merz Dental GmbH·D7091970392·anteriors; shade D2; mould IS
S.I.N. Implant System
FDA 510(k)
FDA Class 2
·Dental
MOSAIC LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ULTRASONIC IMAGING CATHETER - CORONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·February 20, 2013
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·January 25, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 31, 2014
ZILVER PTX 35 DRUG-ELUTING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIU·February 2, 2016
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015