8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CAMPYLOBACTER SELECTIVE SUPPLE-BLASER
FDA 510(k)
FDA Class 1
·Microbiology
FIBERION OPHTHALMIC ENDOLASER PROBE
FDA 510(k)
FDA Class 2
·Ophthalmic
SUNPEX TECHNOLOGIES MODEL SE03
FDA 510(k)
FDA Class 2
·Physical Medicine
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·March 25, 2014
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·November 15, 2012
INBONE TALAR STEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·July 1, 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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018