12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Felix NeuroAI System
FDA 510(k)
FDA Class 2
·Neurology
Vivid ZirDisc Zircon Zahn System
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724Q2500961·95x28mm SHT (Super Translucent)
COE®
FDA UDI
Gc America Inc.·10386040012003·COE® SPACER TRAYS Perforated Assorted Package
COE®
FDA UDI
Gc America Inc.·D6582500961·COE® SPACER TRAYS Perforated Assorted Package
Offset Final Implant Impacter
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057930·
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Crosstex VH2O2 Chemical Indicators
FDA 510(k)
FDA Class 2
·General Hospital
LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·August 28, 2012
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 14, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 15, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013