8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENZYMATIC TRIGLYCERIDES #2000
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
FDA 510(k)
FDA Class 1
·General Hospital
ATAMA SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·December 3, 2025
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·May 27, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2012
RE-MANUFACTURED IPUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 13, 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