10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VS3-IR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551811·IN-OVATION® mini EURO 018/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551821·IN-OVATION® mini EURO 018/5-5 CBC HK
STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
FDA 510(k)
FDA Class 1
·General Hospital
VENTRALIGHT ST MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 22, 2011
M2A-MAGNUM MOD HD SZ 52MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013
IDENTITY ADX XL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code LWP·January 13, 2014
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,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024