24 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Flowtron DVT5 Small Calf Garment
FDA 510(k)
FDA Class 2
·Cardiovascular
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
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989054163·PRLS 2NDMOL B/T 12DEG -10T 022 NDX UR
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100820·FLIERINGA FIXATION RING 21MM
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10887488366227·STRL SINGLE SHOT EPIDURAL TRAY
SKELETAL DYNAMICS STERILIZATION TRAYS
FDA 510(k)
FDA Class 2
·General Hospital
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 11, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·June 15, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·September 23, 2008
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·September 6, 2024
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·September 10, 2024
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·September 6, 2024
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·August 11, 2023
SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·October 14, 2020
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·June 16, 2022
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·September 27, 2024
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·March 29, 2023
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·December 1, 2022
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·December 1, 2022