11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
All-Suture Dual Anchor System
FDA 510(k)
FDA Class 2
·Orthopedic
Power Curve Extra-Soft Toothbrush
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063756595·Power Curve Extra-Soft Toothbrush, imprinted, t...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117469·Distal Reamer (Hudson)
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111566·Modular Stem 9mm x 150mm
ReDs Wearable System
FDA 510(k)
FDA Class 2
·Cardiovascular
Streamline Navigated Instruments
FDA 510(k)
FDA Class 2
·Neurology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Death
·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 7, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013
12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·September 13, 2017
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