12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LO-BAK TRAX
FDA 510(k)
FDA Class 1
·Orthopedic
JOBST SensiFoot
FDA UDI
BSN MEDICAL, INC.·00035664108588·SENSIFOOT 8-15 MM HG KNEE HIGH LARGE BROWN 1 EN...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819094·3.5cm x 15 cm Loughlin-Simpson Retractor
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
FDA 510(k)
FDA Class 2
·Microbiology
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,
FDA 510(k)
FDA Class 2
·Orthopedic
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 8, 2013
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·September 23, 2014
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·June 2, 2011
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 13, 2026
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
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025