9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
BIO-SCIENCE LABORATORIES T4 REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Continuum®
FDA UDI
Zimmer, Inc.·00889024154292·
2300 SERIES MGO PORTABLE OXYGEN
FDA 510(k)
FDA Class 2
·Anesthesiology
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
FDA 510(k)
FDA Class 2
·General Hospital
LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 17, 2024
VISI-PRO¿ BALLOON-EXPANDABLE BILIARY STENT SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code FGE·November 15, 2012
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 27, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 14, 2010
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