19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STERI-DENT, STERI-SURE
FDA 510(k)
FDA Class 2
·General Hospital
JOBST SensiFoot
FDA UDI
BSN MEDICAL, INC.·00035664108670·SENSIFOOT 8-15 MM HG KNEE HIGH MEDIUM BLACK 1 E...
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642108224·Plate, 26 mm/30 mm (W) x 17 mm (H)
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803727·Goulet-Simpson Retractor, Small 1"
VICOR PD2I ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
KILEJIAN CIRCUMCISOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011
PEDIASAT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DQE·March 27, 2025
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025
VERSE POLY DRIVER SHAFT NAV
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code OLO·April 29, 2022
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
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