19 results · 22ms · Sources: EU EUDAMED, US FDA

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VARAYA AR , VARAYA SPORT

FDA 510(k)
FDA Class 2 ·Physical Medicine

Disc Prep

FDA UDI
Life Spine, Inc.·00190837089894·

THE BUZZ FACIAL TONING SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

SYNGO MBF

FDA 510(k)
FDA Class 2 ·Radiology

CRE¿ WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·February 20, 2013

CRE¿ WIREGUIDED

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - CORK·Product code KNQ·September 7, 2012

CRE? WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 18, 2013

CRE¿ WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·January 7, 2013

INTERMATE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 14, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

SHUNT SENSOR SYS500

FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·April 4, 2011

CRE¿ WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·March 13, 2013

CRE¿ WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·August 10, 2012

CRE? WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 6, 2013

CRE¿ WIREGUIDED

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - CORK·Product code KNQ·December 5, 2012

CRE¿ WIREGUIDED

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - CORK·Product code KNQ·July 2, 2012

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

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025