20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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