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Hernia Support,Hernia Truss Suppliers & Manufacturers

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Hernia Support (FDA Code: EXN / 876.597)

Identification. A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening (a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the umbilical truss.

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 876.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records, and 820.198, regarding complaint files.

Ita-med Co, DJ Orthopedics Inc., 3M Medical Specialties, more...

Hernia Truss
SAI Therapeutic Brands, GF Health Products, Inc., Bell-Horn, Inc., more...

Herniorrhaphy Kit
Ethicon Endo-Surgery, Inc.

High Energy Transurethral Microwave Thermotherapy
High Energy Transurethral Microwave Thermotherapy is a thermoablative treatment for benign prostatic obstruction.
American Medical Systems, Fisioline Di Battagliotti Ugo & C S.N.C.

High Flux Re-Use Hemodialyzer (FDA Code: MSF / 876.586)

Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:

Classification. Class II. The special controls for this device are FDA's:

Gambro, Baxter International Inc, Erika De Reynosa, S.A. De C.V., more...

High Permeability with/without Sealed Dialysate System (FDA Code: KDI / 876.586)

Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:

Classification. Class II. The special controls for this device are FDA's:

Edwards Lifesciences Corporation, Transvivo Inc., Fresenius Medical Care North America, more...

Hollow Fiber Capillary Dialyzer (FDA Code: FJI / 876.582)

Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.

Interpore Cross International, Inc., Spectrum Laboratories, Inc., Rismed Oncology Systems, more...

Home Uroflowmetry System
Laborie Medical Technologies

Hot Cystoscopic Rongeur (FDA Code: KDO / 876.15)

Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

Combined Instruments (Pvt.), Ltd.

Hydraulic Cystometric Device (FDA Code: FEN / 876.162)

Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 876.9.

Autosuture, Cooper Surgical, Inc., Mediwatch USA, more...

Hydrophilic Personal Catheter Pediatric
Cook Urological, MedexSupply

Hypoglycemia Alarm
Impact Diagnostic International, Medical Decisions Network, Diabetes Sentry Products Inc.

Hypospadias and Epispadias Repair Stents
Cook Urological

Ileostomy Urinary Bag (FDA Code: EXH / 876.59)

Identification. An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.

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 876.9.

Hollister Incorporated, Cook Group Incorporated, Aesculap Inc., more...

Imaging Systems
Yates X-Ray Co., Inc., KPI Ultrasound, Soma Technology, Inc., more...

Immersable Cystoscopes
Gyrus ACMI, Stryker, Pentax Medical Company, more...

Implant Needles
Medtec, C. r. Bard, Inc., Medical Supplies & Equipment Company LLC, more...

Implantable Electrical Stimulator (FDA Code: EZW / 876.527)

Identification. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor, and a battery-powered transmitter outside the body.

Classification. Class III (premarket approval).

Medtronic Xomed Surgical Products, Inc, Trivirix, Medtronic, Inc., more...

Implanted Fecal Incontinence Device (FDA Code: MIP)
Laserscope, AMS Innovative Center-Phoenix, Ritm Okb Zao, more...

Implanted Hemodialysis Catheter (FDA Code: MSD / 876.554)

Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

Classification. (1) Class III (premarket approval) for the implanted blood access device.

Autosuture, Cook Group Incorporated, Navilyst Medical, Inc., more...

Incontinence Cuffs
KCK Medical, Medmarketplace.com, Southwest Medicals LLC, more...

Incontinence Management, External Catheters
Alsius Corporation, Mentor Corporation, Anthony Products, Inc., more...

Incontinence Management, Incontinence Cuffs
Cook Urological, Eastmed Inc.

Incontinence Protective Garment (FDA Code: EYQ / 876.592)

Identification. A protective garment for incontinence is a device that consists of absorbent padding and a fluid barrier and that is intended to protect an incontinent patient's garment from the patient's excreta. This generic type of device does not include diapers for infants.

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 876.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records, and 820.198, regarding complaint files.

HY Supplies Inc., KCK Medical, Autosuture, more...

Incontinent Care
Mentor Corporation, Halyard Health, Inc., Ionmeds.com, more...

Infection Control Urine Meter Tray
Infection control urine meter tray incorporates a bacteriostatic agent in the drain tube and drain bag material to repel common bacteria & yeasts. It eliminates urine splash when emptying the drainage bag.
Cardinal Health, Inc.

Inflatable Incontinence Cuffs
Cook Urological

Inflatable Penile Implant
Inflatable Penile Implant is a small, self-contained medical device that is implanted in the body to create an erection. Inflatable penile implant consists of two hollow cylinders, which are surgically inserted into the penis. The inflatable penile implant is a two or three-piece device made of polyurethane and filled with sterile fluid.
Mentor Corporation

Inflation Bulb For Endoscope (FDA Code: FCY / 876.15)

Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

Zutron Medical LLC, Teleflex Medical, Bioseal Medical Packaging Concepts, more...

Injectable Bulking Agent (FDA Code: LNM)
C. R. Bard, Inc., Bard Medical Div., Carbon Medical Technologies, Inc., Bioform Medical, Inc., more...

Injection Cannula (FDA Code: FGY / 878.42)

Identification. 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.

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 878.9.

ISPG, Becton, Dickson & Co.,, Kmedic, more...

Insertion Kits
Insertion kit provides an easy and reliable method to randomly insert a transposon containing a phage T7 RNA polymerase promoter into any DNA molecule in vitro.
Cardinal Health, Inc., Rocket Medical, Gyn Disposables, Inc.

Insertion Trays Without Catheter
Cardinal Health, Inc.

Instestinal Clamp Locking Device (FDA Code: FFR / 876.473)

Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

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 876.9.

KLS Martin, L.P., Vyaire Medical, Inc., Luxtec, more...

Insulin Injector
Palco Labs, Owen Mumford Inc., Minnesota Rubber & Plastics Quadion Corp., more...

Integral Filiform Urethral Dilator
Integral Filiform Urethral Dilator is used for traversing and dilating urethral strictures. Its feature includes filiform tip, which replaces the need for separate filiform and followers to dilate the urethra.
Cook Group Incorporated, Cook Urological, Angiomed Gmbh & Co. Medizintechnik Kg, more...

Interconnected Metal Sound (FDA Code: FBS / 876.459)

Identification. An interlocking urethral sound is a device that consists of two metal sounds (elongated instruments for exploring or sounding body cavities) with interlocking ends, such as with male and female threads or a rounded point and mating socket, used in the repair of a ruptured urethra. The device may include a protective cap to fit over the metal threads.

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 876.9.

Vyaire Medical, Inc., Instrumed International, Inc., Combined Instruments (Pvt.), Ltd., more...

Intermittent Catheter Kits
Intermittent catheter kit is a closed system kit designed for sterile intermittent catheterization and offers a pre-lubricated catheter with patented finger guide. This kit contains collection chamber with built-in sample/drainage port, one pair of gloves, providence iodine swabs and under pad.
Cardinal Health, Inc., E Tenn Urological Supplies, Vitaimed Instrument Co., Ltd.

Intermittent Catheters
Intermittent Catheters are hollow tubes used to drain urine from the bladder. This is called intermittent self-catheterisation. Intermittent catheters are of three types such as plain catheters, coated catheters and pre-lubricated catheters. Indwelling catheters are connected to a drainage bag, which holds the urine.
Advanced Diabetes Supply, DMES, Inc., Mentor Corporation, more...

Intermittent Female Catheter
Cardinal Health, Inc., Patient Care Medical, Quality Medical Supply, Inc., more...

Intermittent Self-Catheters
Intermittent Self Catheters are hollow tubes used to drain urine from the bladder. They are inserted at intervals throughout the day or when one feels the need to go to the toilet. There are three main types, such as plain catheters, coated catheters and pre-lubricated catheters.
Alsius Corporation, Uromed Inc., E Tenn Urological Supplies, more...

Intestinal Clamp
Codman & Shurtleff, Inc., Herger AG, Himalaya Trading Co. (Pvt) Ltd., more...

Intestinal Clamp Forceps
Codman & Shurtleff, Inc., International Hospital Supply Co., Virginia Teck Fzc, more...

Intestinal Clamps for Children
Codman & Shurtleff, Inc., Herger AG, Seven Eight & Co, more...

Intestinal Forceps
Elmed Inc., Biomedical Research Instruments, Inc., Codman & Shurtleff, Inc., more...

Intestinal Stimulator (FDA Code: LNQ)
Medtronic Xomed Surgical Products, Inc, Medtronic, Inc.

Intracorporeal Lithotripsy Systems
Gyrus ACMI, Siemens Medical Solutions USA Inc, Elmed Electronics & Medical Industry & Trade Inc., more...

Intragastric For Morbid Obesity Implant (FDA Code: LTI)
Avail Medical Products, Inc., Obtech Medical Sarl, Mcghan Medico, S.A., more...

Iontophoresis Unit
World Precision Instruments, Inc., Wescor Inc., Krupa Medi Scan

Irrigation Delivery System
Gyrus ACMI, Cardinal Health, Inc.

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