13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AQUILION CXL
FDA 510(k)
FDA Class 2
·Radiology
OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS
FDA 510(k)
FDA Class 2
·Radiology
DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070
FDA 510(k)
FDA Class 2
·Cardiovascular
BROCKENBROUGH NEEDLE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO·Product code DRC·September 11, 2018
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013
AUTOPULSE LI-ION BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 15, 2013
EON MINI
FDA Adverse Event
Injury
·ST JUDE MED - NEUROMODULATION·Product code GZB·September 17, 2014
SROM STM STD 36+12L 13X18
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code LPH·May 18, 2011
LOGIC CC FEMORAL SIZE 2, RIGHT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 13, 2023
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025