19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BACTEC 9240 SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
BD BACTEC FX, INSTRUMENT TOP, PACKAGED
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·February 22, 2021
HAMILTON CO.
FDA registration
HAMILTON CO.·4 products·🇺🇸 United States
COMPANION SPEECH AID, MODEL 432
FDA 510(k)
FDA Class 2
·Physical Medicine
DOSE CALIBRATOR
FDA 510(k)
FDA Class 2
·Radiology
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY CMW - 9610921·Product code LOD·February 10, 2020
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY CMW - 9610921·Product code LOD·February 10, 2020
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LOD·June 3, 2021
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY CMW - 9610921·Product code LOD·February 18, 2020
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·November 30, 2010
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 7, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 5, 2012
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY CMW - 9610921·Product code LOD·February 18, 2020
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY CMW - 9610921·Product code LOD·March 19, 2022
INSTRUMENT BACTEC 9240 CR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·July 15, 2021
INSTRUMENT BACTEC 9240 CR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·April 30, 2021
INSTRUMENT BACTEC 9240 CR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·June 1, 2021
BD BACTEC FX TOP SERVICE CONTRACT 5 DAY
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·August 10, 2021
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024