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