12 results
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19ms
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Sources: EU EUDAMED, US FDA
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