8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)
FDA 510(k)
FDA Class 2
·Neurology
PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PHARMACIA B2-MICRO EIA
FDA 510(k)
FDA Class 2
·Immunology
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 16, 2014
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 12, 2010
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM INC.·Product code MDS·December 14, 2012
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 20, 2020
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024