15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
BD ECLIPSE HYPODERMIC NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 10, 2025
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 13, 2017
NEWPORT
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 16, 2017
30 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·February 7, 2019
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 19, 2013
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·September 15, 2014
PSL M/S 3-HOLE CUP
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDJ·May 6, 2011
25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016
27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·November 30, 2016
25 G X 5/8 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·February 24, 2017
27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·November 30, 2016
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020