Femur prosthesis is a useful implant for patients with extensive bone loss at revision arthroplasty. It replaces the entire femur as well as the hip and knee joint, connecting both with a titanium femur.
Innovative Medical Products, Inc
Gotham Medical LLC,
Synthes, Inc.,
Novalign Orthopaedics, Inc.,
more...
Fiberglass cast boot is used to treat non-infected, nonischemic plantar diabetic ulcers. It offers pressure relief and high compliance and decreases the risk of bone infection.
BSN medical, Inc.,
Lactona Corp.,
Mueller Sports Medicine, Inc.,
more...
Advanced Sterilization Products,
Spectrum Laboratories, Inc.,
Alba Healthcare,
more...
Biomet, Inc
(FDA Code:
HTP /
888.454)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 888.9.
Elmed Inc.,
Zimmer, Inc.,
Biomet, Inc,
more...
General Physiotherapy, Inc.
Orthomerica Products, Inc.,
Biomet, Inc,
3-Point Products, Inc.,
more...
Finger circumference gauge is used to measure the circumference of a joint or digit. It can wrap webbing around the finger and read the circumference directly from the ruler.
Alimed, Inc.
Finger Exercisers are designed to strengthen functions of the forearm, hand and fingers while developing coordination, dexterity and improved range of motion. They are also useful as an aid to rehabilitation after a finger injury.
Hub4Health.com,
Donovan Industries Inc,
Patterson Medical Products, Inc.,
more...
Finger goniometer is a tool that can be held and operated with one hand. It measures extension/hyperextension and flexion of the digits from the dorsal surface of the hand for increased accuracy. It is also used for the measurements of metacarpal, phalangeal and interphalangeal joints.
Alimed, Inc.,
King Life Technology Co.,Ltd.
Biomet, Inc,
Advantis Medical, Inc.
Finger prosthesis artificially restores structures congenitally absent or lost to trauma or disease. This prosthesis restores symmetry to the hands, and by restoring length, allows for digital manipulation. This may provide opposition to a remaining mobile thumb or finger(s).
Innovative Medical Products, Inc,
Aesthetic Concerns Prosthetics,
Howmedica International Ltd,
more...
Mizuho OSI,
Zimmer, Inc.,
Alimed, Inc.,
more...
Finger protector splint is used to determine size, measure the length of the affected finger. It is available in small, medium, and large sizes. It is generally made of aluminum material.
Mizuho OSI,
Innovative Medical Products, Inc,
Zimmer, Inc.,
more...
(FDA Code:
NEG)
Ascension Orthopaedics
Royce Medical Company,
iHealthDepot.com,
3-Point Products, Inc.,
more...
Elantec Medical, Inc.,
Covidien,
Ethicon, Inc.,
more...
Ultimate Water Massage
TRUE Fitness,
The Home Gym Supply Center,
Three Rivers Holdings LLC,
more...
Fitness ball is basically a big, somewhat bouncy ball designed for injured patients to be able to get some aerobic conditioning. It is used by physical therapists to rehabilitate back, knee, and hip injuries. It helps to provide master core stability, bal
Innovative Medical Products, Inc,
Accufitness, LLC,
Eb Brands, Llc,
more...
Dynatronics Corporation,
The Home Gym Supply Center,
Isokinetics Inc,
more...
FitnessZone.com,
Alimed, Inc.,
Medical Supplies & Equipment Company LLC,
more...
The Home Gym Supply Center,
Med-Fit Systems
Reha Partner Inc,
Theradapt Products Inc,
Integrated Rehabilitation Systems,
more...
(FDA Code:
JDQ /
888.301)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.
Classification. Class II.
Medtronic Xomed Surgical Products, Inc,
Arthrex, Inc.,
Vyaire Medical, Inc.,
more...
Disposable Instrument Co. Inc.,
Spinal Elements, Inc.,
Onyx Medical Corp.,
more...
Fixed arthroscope consists of a tiny tube, a lens, and a light source. It is inserted into a small incision and allows a surgeon to look for joint damage or disease. This device also allows the surgeon to perform reconstructive procedures on the joint.
Depuy Orthopaedics, Inc.,
Innovative Endoscopy Components, LLC,
Arthrex, Inc.,
more...
General Physiotherapy, Inc.
Flat foot prosthesis is appropriate to perform the function of a bone implant in the calcaneus. It is designed to act as a stop and axis, and therefore has a polished surface as is required in a friction zone. It is made of stainless steel and is available in various sizes and thread lengths. Fragement sets consist of a comprehensive range of integrated implants and instruments including basic, small, mini, pelvic, and foot sets. These sets include an extensive range of high quality implants, including all necessary screws and specialist plates.
Sgarlato Labs,
Innovative Medical Products, Inc,
Seecor, Inc.,
more...
Dynatronics Corporation,
Prepak Products Inc,
Balanced Body Pilates,
more...
Flexible ankle brace is affixed between the shoe sole and insole. It extends upward to engage the ankle and the ends are held together by gripping material. It has two relatively rigid side supports, the outer edge portion of the lower area of the side supports, adjacent to the ankle being covered with a flexible or resilient material. The flexible resilient material is permanently secured to the side supports by bonding, mechanical interlocking, or by any other suitable arrangements.
Royce Medical Company,
DME-Direct Inc.,
DJ Orthopedics Inc.,
more...
(FDA Code:
HTJ /
888.43)
Identification. A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 888.9.
Hayes Medical, Inc.,
Depuy Orthopaedics, Inc.,
Sontec Instruments, Inc.,
more...
Flexible foot switch is a true membrane switch designed to detect gait events in ambulatory subjects. It consists of a durable 25mm diameter membrane switch with a 15mm sensor area on a 100mm flexible tail. The entire switch sensor is only 1mm thick and responds reliably to pressure applied anywhere in the sensor area.
Elmed Inc.
Flexible lateral hip supports provide additional stability at the hip joints for improved upright standing alignment.
Ita-med Co,
DJ Orthopedics Inc.,
Medical Supplies & Equipment Company LLC,
more...
A Flexible Orthotics is used for providing sensory input and body awareness to a person suffering from a neurological disorder, autism, proprioceptive and sensory deficits, or hypersensitivity is disclosed. The orthotic is made from a multidirectional stretchable spandex material.
Bulow Orthotic & Prosthetic Solutions,
Corefit Orthotics,
Footstar Orthotics,
more...
Ultimate Water Massage
Kare Products Inc
(FDA Code:
KIC /
890.3175)
Identification. A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9.
Spectrum Laboratories, Inc.,
Sunrise Medical,
Hollister Incorporated,
more...
Fluid management systems are designed to accurately measure all inputs and outputs of fluids used. These systems are used frequently when performing operative hysteroscopy or with use of high viscosity liquid media. The basic principle of all fluid management systems consists of monitoring the amount of fluid used and monitoring the amount of fluid that is collected after the fluid passes through the uterus. It has collection bags that collect the used and spilled fluid.
Arthrex, Inc.,
Navilyst Medical, Inc.,
Gyrus ACMI,
more...
(FDA Code:
LBG /
890.55)
Adroit Medical Systems
(FDA Code:
LSB /
890.51)
DJO Incorporated,
Quality Health Products, Inc.,
Chattanooga Group,
more...
Allman Products Inc.,
Marcon Group, Inc.,
Val Med,
more...
Tensnet,
Alimed, Inc.,
St. Louis Medical Supply Inc.,
more...
Foam Cervical Pillow keeps the neck and head well aligned with the spine while sleeping. It reduces the pressure on the neck.
McCarty's Sacro-Ease,
Zimmer, Inc.,
Biomet, Inc,
more...
Brown Medical Industries,
Dealmed Medical Supplies
National Medical Alliance,
1-800-Wheelchair Inc.,
Gendron, Inc.,
more...
Folding gym mats are lightweight and fold into two-foot widths for easy stacking or storage. These mats are versatile and can be used as tumbling gym mats or hung on the wall for wall protection. These mats come in a variety of thicknesses, colors, and si
Innovative Medical Products, Inc,
Alimed, Inc.,
Durable Corporation,
more...
Folding walkers are designed for use by individuals with mobility or walking disabilities. It is generally made of aluminum materials. It can also be made of plastic. This frame walker has ergonomic handgrips shaped for arthritic hands.
Royce Medical Company,
American-Medical-Supply.com,
DJ Orthopedics Inc.,
more...
DePuy Orthopaedics, Inc,
Carniaflex Srl