21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
APEX™
FDA UDI
B. BRAUN MEDICAL INC.·04046964539121·EVA Single-Chamber Final Containers 500 mL
D2RF DIGITAL DYNAMIC REMOTE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ROK
FDA 510(k)
FDA Class 2
·Dental
BD BBL¿ GRAM CRYSTAL VIOLET
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code JTS·August 28, 2025
B.BRAUN
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL INC.·Product code LHI·January 10, 2019
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011
STONYBROOK HSP NY NY 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 14, 2013
SECURE ACUTE CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 25, 2011
LIFEPAK 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008
BD BBL¿ GRAM CRYSTAL VIOLET
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code JTS·August 28, 2025
APEX¿
FDA Adverse Event
Malfunction
·B. BRAUN AVITUM ITALY S.P.A.·Product code KPE·September 12, 2018
C21785 IT TREVISO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code GEI·December 14, 2012
BD BBL¿ GRAM CRYSTAL VIOLET
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code JTS·January 26, 2026
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·May 18, 2022
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·March 17, 2022
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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