15 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102
FDA 510(k)
FDA Unclassified
·Unknown
REACH(R) FEMORAL PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304307063·
JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP
FDA 510(k)
FDA Class 1
·Physical Medicine
COMPACT PIEZO P2K, POWERCARE
FDA 510(k)
FDA Class 2
·Dental
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
TOTAL ASR FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·July 7, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·September 16, 2008
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
MARKSMAN
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·September 11, 2023
PIPELINE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 11, 2023
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·March 23, 2018
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024