25 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·July 25, 2012
GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions
FDA Enforcement
Class II
·Terminated·Pega Medical Inc.·April 8, 2015
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
FDA Enforcement
Class II
·Ongoing·GRAMERCY EXTREMITY ORTHOPEDICS·April 26, 2023
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED BIOPSY TRAY, REF 89-8753.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED CATARACT PACK, REF 89-5790.08
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·September 26, 2012