10 results
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18ms
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Sources: EU EUDAMED, US FDA
VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
FDA 510(k)
FDA Class 2
·Immunology
OPHTEC BV
FDA registration
OPHTEC BV·4 products·🇳🇱 Netherlands
IVD (IN VIVO DOSIMETER), MODEL 1131
FDA 510(k)
FDA Class 2
·Radiology
SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 19, 2025
ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM
FDA Adverse Event
Malfunction
·HAEMONETICS CORP.·Product code CAC·April 3, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 5, 2011
FREESTYLE LITE
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC. USA·Product code LFR·May 8, 2008
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018