10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Neu Platform
FDA 510(k)
FDA Class 2
·Neurology
Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90925015313·.020 LOWER SS RIGHT FORM ARCHWIRES (50)
Sapphire NC Plus
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955934643·Percutaneous Transluminal Coronary Angioplasty ...
CERTAIN¿ TITANIUM HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·December 14, 2022
SPIRIT, MODEL HAS
FDA 510(k)
FDA Class 2
·Anesthesiology
Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MBT CEM KEEL TIB TRAY SZ2.5
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code NJL·September 15, 2011
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 22, 2013
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·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