Profile: Bioform Medical, Inc. is specialised in medical aesthetics. We provide commercial and core technology products. Our product Radiesse® dermal filler and Coaptite® injectables have been through significant safety and effectiveness testing, including bio compatibility testing, preclinical studies and several multi-center human trials. Our dermal filler is a synthetic injectable material that is suspended in an aqueous gel carrier. This gel carrier allows for controlled placement, and permits the practitioner to manipulate dermal filler after injection without unwanted migration of the particles. These dermal fillers indicate the correction of moderate to severe folds and wrinkles, such as nasolabial folds, as well as facial lipoatrophy or facial fat loss, and for treating patients with human immunodeficiency virus. We also offer Aethoxysklerol® sclerosing agent and BioGlue® surgical adhesive.
FDA Registration Number: 2135225
17 Products/Services (Click for related suppliers)
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| • Aesthetic Dermal Implant (FDA Code: LMH) |
| • Aesthetic Enhancement |
| • Catheter Needle (FDA Code: GCB / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles. |
| • Cosmetic Microsurgical Instruments |
| • Cosmetic Surgery Instruments |
| • Dermal Fillers |
| • Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
| • ENT Synthetic Polyamide Polymer (FDA Code: KHJ / 874.3620) Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene. |
| • Implantable Radiographic Marker (FDA Code: NEU / 878.4300) An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable. |
| • Implantable Staple (FDA Code: GDW / 878.4750) An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable. |
| • Injectable Bulking Agent (FDA Code: LNM) |
| • Injectable Dermal Fillers |
| • Injectable Implants |
| • Radiofrequency Lesion Generator (FDA Code: GXD / 882.4400) A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites. |
| • Radiofrequency Lesion Probe (FDA Code: GXI / 882.4725) A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired. |
| • surgical adhesive |
| • Vocal Cord Medialization System (FDA Code: MIX / 874.3620) |