2 Or Two Way Foley Catheter,2.7 mm Cystoscopes Suppliers & Manufacturers

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2 Or Two Way Foley Catheter
Mentor Corporation, Rochester Medical Corporation, PRO2 Medical

2.7 mm Cystoscopes
Gyrus ACMI, Stryker, Pentax Medical Company, more...

200 mm Length Mini Cystoscopes
Gyrus ACMI, Stryker, Pentax Medical Company, more...

24 Hour Uroflowmetry System
Laborie Medical Technologies

3 Or Three Way Foley Catheter
Mentor Corporation, Cook Urological, PRO2 Medical

3-Way Catheters With Couvelaire Tip
3 - Way catheters facilitate large irrigation lumen for effective flow of irrigation fluid. These catheters are made up of large drainage lumen for quick flow of urine. It is adequately stiffer to withstand traction after TURP surgery. Foley catheters used in these surgical procedures are called 3-way catheters.
Cardinal Health, Inc.

302 mm Length Cystoscopes
Gyrus ACMI, Stryker, Pentax Medical Company, more...

4 mm Cystoscopes
Gyrus ACMI, Stryker, Pentax Medical Company, more...

5Cc Two-way Foley Catheters
Mentor Corporation, Teleflex Medical, Cardinal Health, Inc., more...

A.V. Fistula Needle
Exel International Medical Products, B. Braun Medical Inc., Baxter International Inc, more...

A.V.Fistula Needle Set
Exel International Medical Products, B. Braun Medical Inc., Baxter International Inc, more...

Abdominal Belt
Ita-med Co, Hospital Marketing Services Co., Inc., Zimmer, Inc., more...

Abdominal Trocar
Laserscope, Autosuture, Elmed Inc., more...

Abdominal Ultrasound Scanner
KPI Ultrasound, Covidien, Microtek Medical, more...

Acid Glucose Bicarbonate Ph Dialysate Strip Indicator (FDA Code: NTZ / 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.

Serim Research Corp.

Adult Bibs
American Dawn, American Associated Companies,Inc., St. Louis Medical Supply Inc., more...

Air Bubble Detectors (FDA Code: FJF / 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.

ZEVEX Inc., Minntech Corporation, Biomerieux Industry, more...

Air Bubble Monitor (FDA Code: FJF / 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.

ZEVEX Inc., Minntech Corporation, Biomerieux Industry, more...

Air Displacement For Body Composition Analysis Plethysmograph (FDA Code: OAC / 870.277)

Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

Classification. Class II (performance standards).

Life Measurement, Inc.

Air Or Foam Detector (FDA Code: KQR / 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.

Arkray Factory USA, Inc., Biocare Corp.

Ambulatory Urodynamic Monitoring System
Ambulatory urodynamic monitoring system is used to quantify abdominal pressure using bio-impedance. It is ideal for investigating lower urinary tract function.
Raytel Medical Corporation, New York Blood Center

Ambulatory Urodynamics Systems
Ambulatory Urodynamics Systems features complete range of microtip catheters, user-definable measuring protocols, transducer positioning & checking function, on-line wireless capabilities, automatic detrusor contraction detection, automatic flow artefact removal and siroky flow rate nomogram. Ambulatory urodynamics systems have three main components such as transducers, a recording unit and an analyzing system.
Medical Measurement Systems, Neomedix Systems

Amplatz Renal Dilator Set
Amplatz Renal Dilator Set is used for progressive dilatation of the nephrostomy tract prior to percutaneous stone removal.
Cook Urological, Surgimedik Healthcare India Pvt. Ltd.

Amplatz Renal Dilators
Amplatz Renal Dilators are used for dilation of a tract to the kidney for removal of stones.
Cook Group Incorporated, Chand Jee Mfg.Co.

Amplatz Renal Dilators with Sheaths
Amplatz Renal Dilators are used for dilation of a tract to the kidney for removal of stones.
Chand Jee Mfg.Co., Medikit Co., Ltd.

Amplifier & Transducer Pressure External Recorder (FDA Code: FES / 876.1725)

Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.

Classification. Class II (performance standards).

Medtronic Neuromodulation, Parama Co. Ltd.

Ampule
Fisher Scientific International, Inc., North Safety Products U.S.A., Avanti Polar Lipids, Inc., more...

Ampule Opener
Fisher Scientific International, Inc.

Anastomosis For Gastro-Urology Use Device (FDA Code: LNN)
Chase Medical

Anoscope and Accessories (FDA Code: FER / 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).

Vyaire Medical, Inc., Luxtec, Codman & Shurtleff, Inc., more...

Anti-Regurgitation Valve with Blood Tubing Set (FDA Code: FJK / 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.

Edwards Lifesciences Corporation, Hospira, Inc., Rockwell Medical Technologies, Inc., more...

Applicator For Rectal Suppository (FDA Code: OOW / 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.

Christcot Medical Company, Apothecary Products, Inc.

Arched Resection Electrode
Gyrus ACMI, ACE Medical Devices Pvt. Ltd.

Areolar Connective Tissue Grafts In Pediatric
Cook Group Incorporated, Gyrus ACMI

Arteriovenous Shunt
Angiodynamics, Inc., Cormedica, Instrumentation Laboratory SpA

Arthoscopic Electrodes
Instrumed OEM, Seven Eight & Co, Urotech Devices

Automated Urine Cell Analyzer
Automated urine cell analyzer is a device used for the analysis of microscopic formed elements in urine specimens. It is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. It analyzes many parameters in urine samples that include RBC, WBC, epithelial cells, cast, and bacteria.
Becton, Dickson & Co.,, Konan Medical Inc., Bayer-Medical Co. Ltd., more...

Automated Urine Chemistry Analyzers
Automated urine chemistry analyzers are designed for high-volume urine testing procedures. It usually provides a 12-test profile, including nine chemistries, specific gravity by refractometer, color, and clarity. These analyzers can operate with batches of 60 to 210 patient specimens with the addition of optional load/unload trays and has continuous loading capability.
Roche Molecular Systems, Inc, Iris Diagnostics, Becton, Dickson & Co.,, more...

Automated Urine Chemistry Reagent Strip Analyzer
Automated urine chemistry reagent strip analyzer is used to test and analyze bilirubin, color, glucose, ketones, leukocyte esterase, nitrite, occult blood, pH, protein, specific gravity, and urobilinogen. It uses a roll of reagent strips affixed to a clear plastic support. Urine specimens are automatically pipetted onto these strips. The instrument measures the pads' color using reflectance colorimetry. Specific gravity is measured using a fiberoptic refractive index method.
Becton, Dickson & Co.,, Randox Laboratories Ltd.

Automated Urine Microscopy Analyzer
Iris Diagnostics

Automatic Blood Tubing Clamp (FDA Code: FIG / 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.

Fisher Scientific International, Inc., Teleflex Medical, Dravon Medical, Inc., more...

Automatic Carbon-Dioxide Insufflator (FDA Code: FCX / 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).

Elmed Inc., E-Z-EM Inc., Teleflex Medical, more...

Automatic Clip Appliers
Automatic Clip Appliers are available with titanium clips in a range of sizes and used to ligate a variety of tissue structures & to perform dissection.
Kroslak Enterprises, Inc., Kmedic, MSI Precision Specialty Instruments

Automatic Delivery Peritoneal System (FDA Code: FKX / 876.563)

Identification. (1) A peritoneal dialysis 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 a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.

Classification. Class II (performance standards).

Spectrum Laboratories, Inc., Autosuture, Haemonetics Corporation, more...

Automatic Needle Shielding System
North American Scientific, Inc., Medtec, C. r. Bard, Inc., more...

Automatic Pneumoperitoneum Apparatus (FDA Code: FDP / 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).

Ethicon, Inc., Ethicon Endo-Surgery, Inc., Entracare, LLC, more...

Autonomous Extracorporeal Blood Leak Detector/Alarm (FDA Code: ODX / 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.

Redsense Medical Ab

AV Shunt Accessories (FDA Code: KNZ / 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, C. R. Bard, Inc., Bard Medical Div., Angiodynamics, Inc., more...

AV Shunt Cannula (FDA Code: FIQ / 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, ICU Medical, Inc, Angiodynamics, Inc., more...

AV Shunt/Fistula Adapter (FDA Code: KNR / 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.

Angiodynamics, Inc.

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