11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
FDA 510(k)
FDA Class 2
·Cardiovascular
BD ULTRA-FINE¿ PRO PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 13, 2022
Bathtub
FDA UDI
Ropox A/S·05707581000393·
MODIFICATION TO TRIPTER X-1 COMPACT DUET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAM STRUCTSURE BARS
FDA 510(k)
FDA Class 2
·Dental
BD AIG BC PRO GLOBAL
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 27, 2024
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 4, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DQO·May 31, 2011
INTIMA-II 22GAX1.00IN PRN SLM NPVC
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·January 30, 2020
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021