12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
FDA 510(k)
FDA Class 1
·Hematology
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 31, 2018
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 18, 2018
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·March 8, 2022
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 10, 2019
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MOLECULAR BREAST IMAGING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 11, 2013
SPIDERFX EMBOLIC PROTECTION DEVICE
FDA Adverse Event
Injury
·EV3 INC.·Product code NTE·November 23, 2010
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014
ALT XLE LNR NTRL G6 36
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code LPH·May 30, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024