7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
URINE ANALYZER SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MAMMI
FDA 510(k)
FDA Class 2
·Radiology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 30, 2014
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 20, 2012
PATIENT ROOM WALL SAVER RECL
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FRK·September 10, 2010
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