15 results · 35ms · Sources: EU EUDAMED, 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