The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN transmits a low-intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. Low-intensity pulsedultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing.The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.

Replacement Main Operating Unit (MOU) for the EXOGEN Ultrasound Bone Healing System, device identifier M937710344001.

The EXOGEN device provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. The EXOGEN Ultrasound Bone Healing Systems has been designed both for use with conservatively treated fresh fractures and non-unions or surgically treated non-unions. The device transmits a low intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. The low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. The device automatically alerts the patient in case of improper application or device performance. The EXOGEN Ultrasound Bone Healing System consists of one main operating unit, gel bottles and strap. The main operating unit provides the treatment control circuitry, the primary battery supply, and monitors the operation of the transducer at the fracture site. The signal specifications cannot be changed.

Replacement MOU for the EXOGEN® Ultrasound Bone Healing System, device identifier M937710346001.

Secure Strand with Advantage I-125 in Strand Delivery System

Brachytherapy Kit: Advantage-Strand and Advantage-Load with Pd-103 radioactive seeds.

Advantage-Strand® with Advantage Pd-103® radioactive seeds.

Advantage-Load® with Advantage Pd-103® radioactive seeds.

Brachytherapy Kit: Secure Strand® and Advantage-Load® with Pd-103 radioactive seeds.

Secure Strand® with Advantage Pd-103® radioactive seeds

Advantage Pd-103 radioactive seeds with a molded form that is shielded on one side containing grooved positions for manual brachytherapy sources on the other side used for the temporary topical application of brachytherapy sources to the surface of the eye; sterile.

Palladium-103 radioactive seed, non-sterile.

Advantage Pd-103 radioactive brachytherapy seeds; non-sterile.

Advantage Pd-103® radioactive brachytherapy seeds, sterile.

Advantage Pd-103® radioactive seeds, sterile.

Advantage Pd-103 radioactive brachytherapy seeds in a cartridge; non-sterile.

Advantage Pd-103 radioactive brachytherapy seeds in a cartridge, sterile.

Radioactive seed localization needle, multi-lengths and configs

Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

Radioactive seed localization, seed and spacer stranded.

Radioactive Seed Localization Needle with I-125 seed, spacer, strand

Radioactive Seed Localization, seed and spacer, 12 cm

Radioactive Seed Localization Needle with I-125 seed and spacer

Radioactive seed localization, seed only, 12 cm

Radioactive Seed Localization Needle with I-125 seed

Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle

MIS Fusion Plate

MIS Fusion Plate

MIS Fusion Plate

MIS Fusion Plate

MIS Fusion Plate

MIS Fusion Plate

MIS Fusion Plate

MIS Fusion Plate

Guidewire, Trocar

Asm, Rampart-O

Asm, Rampart-O

Asm, Rampart-O

Asm, Rampart-O

Asm, Rampart-O

Asm, Rampart-O

Asm, Rampart-O

Asm, Rampart-O

Asm, Rampart-O

Asm, Rampart-O