13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
CPS Locator 3D Delivery Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776304447·Hibbs Osteotome 9.5", straight, 1 18"
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188155·Integra® Jarit® Hibbs Osteotome, 9-1/2", Straig...
Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90925014716·.018 X .025 UPPER SS RIGHT FORM ARCHWIRES (10)
CONMED
FDA UDI
Conmed Corporation·10845854021590·OSCILLATING SAW BLADE 25 X 1.47 X 90 MM
Rx Knee Femoral Augment
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215123352·
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Lubrigyn cream
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·September 15, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 22, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·July 26, 2013
AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
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