7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
ULTRASONIC DENTAL PROPHYLAXIS UNIT
FDA 510(k)
FDA Class 2
·Dental
DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
FDA 510(k)
FDA Class 2
·Radiology
PIEZON 150
FDA 510(k)
FDA Class 2
·Dental
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 27, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 14, 2012
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2015
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015