21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
STARLED5 NX
FDA UDI
ACEM SPA·08050705890514·STARLED5 NX 1-ARM CEILING MIDLINE
MEGA PLUS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665582232·LED Rod, Ø5.5 x 70-70mm
MEGA PLUS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665582195·LED Rod, Ø6.0 x 70-70mm
Leva® Anterior Expandable Spacer System
FDA UDI
Spine Wave, Inc.·10840642109252·Spacer, 30 mm (W) x 28 mm (D) x 17 mm (H), 8° L...
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521107070·
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046605·
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100070·Tray Insert 1, NIDO
REPROCESSED PINS
FDA 510(k)
FDA Class 2
·Orthopedic
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
FDA 510(k)
FDA Class 2
·Cardiovascular
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 1, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 8, 2019
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 26, 2018
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 6, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2021
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