9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ANTITUBERCULOUS DRUGS (SIRE)
FDA 510(k)
FDA Class 2
·Microbiology
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788223290·Cervical Trial 11x18x14 Lordotic
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
BIOJET
FDA 510(k)
FDA Class 2
·Radiology
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·May 20, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 7, 2012
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·September 1, 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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025