9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PHASE II T3 RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOSPACE
FDA 510(k)
FDA Class 2
·Cardiovascular
INVACARE POLARIS EX CPAP, MODEL ISP3000
FDA 510(k)
FDA Class 2
·Anesthesiology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 23, 2014
RESTORATION ADM. CUP W/HA
FDA Adverse Event
Injury
·STRYKER ORHTOPAEDICS CORK·Product code MEH·November 2, 2012
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·September 7, 2010
BELLATEK TITANIUM ABUTMENT 4.1MM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·July 27, 2023
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