19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ActivOrtho Continuous Compression Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PALINDROME RT CHRONIC CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 22, 2016
STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021
STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022
TENDRIL ST
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code NVN·January 13, 2014
UNKNOWN M2A MAGNUM HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 22, 2011
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025
M-VIZION PROXIMAL BODY HANDLE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026
STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2021
M-VIZION INSERTER ROD
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·May 28, 2024
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024