9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BTC URINE LCG ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAPIO
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code FHQ·September 22, 2009
CAPIO
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC, MIAMI TECHNOLOGY CTR·Product code MFJ·October 14, 2005
CLICKFINE PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
CYNOSURE SMART FILE ND:YAG LASERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 23, 2014
UNKNOWN HIP SYSTEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·November 2, 2012
RIATA PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·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