19 results · 23ms · Sources: EU EUDAMED, US FDA

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SYMPHONY GRAFT DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

SCANLAN®

FDA UDI
SCANLAN INTERNATIONAL INC·00846159028805·Dennis Multi-Purpose Clamp

ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

BRAHMS DIAGNOSTICA LUMITEST ANTI-TG

FDA 510(k)
FDA Class 2 ·Immunology

SYNERGY VERSITREL

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 24, 2017

TRIAGE CARDIAC TRIPLE MARKER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 12, 2018

TRIAGE CARDIAC HS PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 22, 2019

TRIAGE CARDIAC TRIPLE MARKER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code MMI·May 18, 2018

TRIAGE CARDIAC PANEL KIT

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code JHX·April 18, 2018

TRIAGE CARDIAC HS PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 21, 2019

TRIAGE CARDIAC TRIPLE MARKER PANEL

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code MMI·October 5, 2017

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 28, 2011

DAMON COPPER NITI WIRE

FDA Adverse Event
Malfunction ·ORMCO CORP.·Product code DZC·February 27, 2008

TRIAGE CARDIAC TRIPLE MARKER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·November 1, 2018

TRIAGE CARDIAC TRIPLE MARKER PANEL

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code MMI·May 17, 2017

bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

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

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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