21 results · 22ms · Sources: EU EUDAMED, US FDA

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STRYKER PLATING SYSTEM BASIC FRAGMENT SET

FDA 510(k)
FDA Class 2 ·Orthopedic

ASIA MED

FDA UDI
asia-med GmbH·04251282509378·asia-med Kinesiology Tape - Royal Blue: made o...

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040009130·Zirlux 16+ 0M3 89x17x25

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033369876·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033369869·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033369852·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033369838·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033369845·

IV SET AN122 W/O PUMP T-TYPE

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 13, 2021

EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

0009613348-2024-012162

FDA Adverse Event
Injury ·INSTITUT STRAUMANN AG·Product code DZE·September 12, 2024

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013

LANDMARX EVOLUTION PLUS

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION·Product code HAW·February 1, 2011

BD DISCARDIT II 2 ML SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 9, 2021

COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·August 29, 2017

UNKNOWN

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·July 10, 2017

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022