20 results · 25ms · Sources: EU EUDAMED, US FDA

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PARKER 500

FDA 510(k)
FDA Class 2 ·Physical Medicine

PRELOADED TISSUE MARKER DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TAKE ONE BITE MODIFIED

FDA 510(k)
FDA Class 2 ·Dental

CONTOUR

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012

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

ALIGN S URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·BARD SHANNON LIMITED·Product code OTN·May 8, 2013

RELIANT

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code DQY·September 23, 2014

SERVO-S

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·April 28, 2011

Cook Access Plus

FDA UDI
COOK INCORPORATED·00827002098305·Cook Access Plus, Check-Flo Performer, Introduc...

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

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

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