16 results · 22ms · Sources: EU EUDAMED, 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