21 results · 21ms · Sources: EU EUDAMED, 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