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

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POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D

FDA 510(k)
FDA Class 2 ·Cardiovascular

SCANLAN® Needle Holders

FDA UDI
SCANLAN INTERNATIONAL INC·00846159003383·Richards Micro Needle Holder

MEDALLION MODULAR HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304640023·

SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

3M RELY X VENEER CEMENT TRY-IN PASTER

FDA 510(k)
FDA Class 2 ·Dental

ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR

FDA Adverse Event
Malfunction ·KESTRA MEDICAL TECHNOLOGIES, INC.·Product code MVK·December 30, 2025

DRIVE SHAFT-MINIMUM 520 MM LENGTH-FOR USE WITH

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HTO·February 28, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·March 1, 2011

COBE MONITOR LINE

FDA Adverse Event
Injury ·SORIN CO·Product code DWF·February 23, 2008

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

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024