8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LYSOSTAPHIN REAGENT SET
FDA 510(k)
FDA Class 1
·Microbiology
VOLU-SOL ORANGE G-6 STAIN
FDA 510(k)
FDA Class 1
·Hematology
MRI-CADDY
FDA 510(k)
FDA Class 2
·General Hospital
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code LWJ·May 23, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 13, 2012
WANDA PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·September 10, 2010
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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