11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
FDA 510(k)
FDA Class 1
·Dental
RELIEVA STRATUS MICROFLOW SPACER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016
OPTI-FREE PLUS
FDA Adverse Event
Injury
·ALCON LABORATORIES, INC.·Product code LPN·December 12, 2017
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 28, 2013
ALTRX +4 10D 36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 31, 2011
SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO·Product code MSX·August 1, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·October 19, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024