9 results
·
35ms
·
Sources: EU EUDAMED, US FDA
DUPONT PREP FOUR-SOLVENT RETROFIT KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
AIR ASPIRATOR NEEDLE
FDA 510(k)
FDA Class 1
·Cardiovascular
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 22, 2014
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·October 29, 2012
GPS STRETCHER FRAME
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·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
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025