13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Star E900 Handpiece Series
FDA 510(k)
FDA Class 1
·Dental
MLKJ
FDA UDI
Weifang Mingliang Electronics Co., Ltd.·06974077940023·
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455530·Integra® Jarit® Cobb Style Bone Curette, Hollow...
Oticon
FDA UDI
Sbo Hearing A/S·05714464053087·OTICON ZIRCON 1 MINIRITE R C091
Sapphire NC Plus
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955916953·Percutaneous Transluminal Coronary Angioplasty ...
ONE TOUCH BASIC
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·October 7, 2002
CS 9600
FDA 510(k)
FDA Class 2
·Radiology
BISX
FDA 510(k)
FDA Class 2
·Neurology
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 28, 2025
INTERLINK CATHETER EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 24, 2008
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·September 9, 2011
3MM FLUTED BALL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GFF·July 17, 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