12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Sklar®
FDA UDI
SKLAR CORPORATION·10649111022319·DITTEL SOUND STR 11.5" 38FR
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209110063·KIT, CRISIS INCIDENT RESPONSE - BLK
Bose Frames
FDA UDI
BOSE CORPORATION·00017817819978·Tenor style prescription ready sunglasses.
Bose Frames
FDA UDI
BOSE CORPORATION·00017817839549·Tenor style prescription ready sunglasses. Wa...
Bose Frames
FDA UDI
BOSE CORPORATION·00017817827546·Tenor style refurbished sunglasses, prescriptio...
CYBERLITH PROGRAMMER
FDA 510(k)
FDA Class 3
·Cardiovascular
Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SMALLBORE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPB·March 26, 2014
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 29, 2012
IMMULITE 2500 HCG ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code DHA·September 23, 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