13 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VANGUARD REMOVABLE MOLDED POLY TIBIA
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540134455·ZYGOMA ELEVATOR, ROWE, BLUNT
GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIR·August 19, 2025
PRAIRIE CRUISER
FDA 510(k)
FDA Class 2
·Physical Medicine
ERCHONIA PL2000
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2025
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·May 1, 2013
VALIANT CAPTIVIA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·September 19, 2014
16FR ULTRAMER (LTX) DRAIN BAG F
FDA Adverse Event
Malfunction
·COVIDIEN·Product code KOD·May 20, 2011
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·Product code FOZ·June 25, 2021
Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
FDA Enforcement
Class I
·Ongoing·Nurse Assist, LLC·December 27, 2023
MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy.
FDA Enforcement
Class II
·Terminated·Thayer Intellectual Property, Inc.·December 14, 2016
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