16 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RESOLVE BILIARY LOCKING DRAINAGE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517575050·CoRoent Ant TLIF Ti, 14x11x40mm 8°
Oticon
FDA UDI
Oticon A/S·05707131271426·RIA, KIT 10 WL OMNI 75 BE
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037336·Unitek(TM) Bicuspid Band General Purpose Wide L...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857581036·Split Tube Retractor Ø12x100 mm
MICROGARD II
FDA 510(k)
FDA Class 2
·Anesthesiology
POLYMEDCO OC AUTO MICRO 80 FOB TEST
FDA 510(k)
FDA Class 2
·Hematology
AN UNSPECIFIED BD¿ INTIMA II
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·March 20, 2019
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·November 28, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014
PLIVIOS SIZ 7 PEEK
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MQP·June 3, 2013
CUB PEDIATRIC CRIB-FIXED BASE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FMS·June 1, 2011
CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
FDA Adverse Event
Malfunction
·THORATEC SWITZERLAND GMBH·Product code DWA·September 17, 2025
BD FACS 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025