PMT Corporation,
Asa Benelux
(FDA Code:
MRD)
Byron Medical, Inc.,
Specialty Surgical Products Inc,
Mcghan Medico, S.A.
Breathing hose is a flexible non-collapsible tube through which air or oxygen flows to the face piece of a respirator. It is designed to deliver air to a patient, with or without added oxygen, from a positive pressure respiratory therapy device such as CPAP and Bi-level device.
Levitation Systems Inc.,
Saint-Gobain Performance Plastics
Rusch Inc.,
Cambrian Medical Inc.,
The Respiratory Solution,
more...
Well Lead Medical Co. Ltd,
Vitaid Ltd.
Bronchial blockers are useful for providing one-lung ventilation during thoracic surgery. Bronchial blockers are used for attempting lung isolation in patients with tracheal bronchus. A blocker is a balloon on a suction catheter and is placed under direct or fibreoptic vision into the bronchus. These blockers allow continued inflation of one lobe of the operated lung and allow right upper lobe ventilation when the operation is on the lower lobe.
Nellcor Puritan Bennett LLC.,
Cook Medical, Inc.,
Vitaid Ltd.
Clinimed, Inc.,
Codman & Shurtleff, Inc.,
Miltex, Inc.,
more...
Clinimed, Inc.,
Codman & Shurtleff, Inc.,
Miltex, Inc.,
more...
Clinimed, Inc.,
Codman & Shurtleff, Inc.,
Miltex, Inc.,
more...
Clinimed, Inc.,
Codman & Shurtleff, Inc.,
Miltex, Inc.,
more...
Morton Medical, Limited
Millennium Surgical Corp.,
Cell Projects Ltd
C. r. Bard, Inc.,
Vector Surgical, LLC
Roboz Surgical Instrument Co., Inc.,
Aspen Surgical Products,
Scanlan International,
more...
Roboz Surgical Instrument Co., Inc.,
Biomedical Research Instruments, Inc.,
Codman & Shurtleff, Inc.,
more...
HNM Medical,
Roboz Surgical Instrument Co., Inc.,
Biomedical Research Instruments, Inc.,
more...
HNM Medical,
Roboz Surgical Instrument Co., Inc.,
Biomedical Research Instruments, Inc.,
more...
(FDA Code:
OJI)
Patterson Medical Products, Inc.
(FDA Code:
OJJ /
878.4022)
Roi, Consolidated Service Center (CSC)
WestPoint Surgical,
Medtronic Xomed Surgical Products, Inc,
Brasseler USA,
more...
American Environmental Health & Safety,
Unipack Medical Corporation,
Square One Medical
Elmed Inc.,
Kirwan Surgical Products,
Gyrus ACMI,
more...
Caliper is a device used to measure the distance between two symmetrically opposing sides. A caliper is as simple as a compass with inward or outward-facing points. The tips of the caliper are adjusted to fit across the points to be measured. They are used in the metalworking field of mechanical engineering, handloading, woodworking and woodturning. Calipers are used by glassblowers to measure outside diameters, inside diameters, wall thickness and other dimensions specified by the drawings used in fabricating glass apparatus.
AZReam, Inc.,
Mackin Manufacturing,
Marina Medical Instruments Inc.,
more...
Alimed, Inc.
Alimed, Inc.,
Microtek Medical,
Preferred Medical Products, Inc.,
more...
(FDA Code:
MUL /
878.44)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification. Class II.
Cameron-Miller, Inc.,
D4 Surgicals India Pvt. Ltd
Iscon Surgicals Limited
Cooper Surgical, Inc.,
Milex Products, Inc.,
Enterix Inc,
more...
B&H Surgical,
Accolade Surgical Products,
Cooper Surgical, Inc.,
more...
Autosuture,
Guidant Corporation
Capsule endoscope is a naturally ingested device for use in the gastrointestinal tract. Natural peristalsis moves the capsule smoothly and painlessly throughout the gastrointestinal tract, transmitting color video images as it passes. The procedure is ambulatory, allowing patients to continue daily activities throughout the endoscopic examination. Capsule endoscopy closes the diagnostic gap by enabling physicians to directly view the entire small intestine. This diagnostic solution can assist physicians in the diagnosis and treatment of gastrointestinal diseases.
Given Imaging Inc.,
Island Medical Ltd
Specialty Blades, Inc.,
Jota Ag
Acetylene Oxygen Company,
Aga Linde Healthcare P.R. Inc.
Cardiovascular imaging systems employ X-rays to image cardiovascular structures, allowing efficient, non-invasive examination of cardiac systems. It consists of gantry that collects X-ray data, rotates around a table where a patient is situated during the examination.
Toshiba Medical Systems,
Philips Medical Systems, N.A.,
California Imaging Services,
more...
Siemens Medical Solutions USA Inc,
Osypka Medical, Inc.,
Lyons Medical Instrument Corp.,
more...
Medi Globe Inc.,
Surgical Tools, Inc.,
Insightra Medical, Inc.,
more...
Stille Surgical, Inc.,
Merit Medical Systems, Inc.,
Insightra Medical, Inc.,
more...
Edwards Lifesciences Corporation,
VasoNova, Inc.,
R-Group International,
more...
Codman & Shurtleff, Inc.,
Kaisers Surgical Instruments Pty Ltd
(FDA Code:
FSZ /
878.458)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
Classification. Class II.
Medtronic Xomed Surgical Products, Inc,
Medtronic, Inc.
Pro Orthopedic Devices,
DENOVO Dental Inc.,
Masel,
more...
Masel,
Becton, Dickson & Co.,,
Vectorvision,
more...
GeoSurgical, LLC,
Ethicon, Inc.,
Victor Surgical Gut Manufacturing Co.,
more...
(FDA Code:
GCE /
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.
Autosuture,
Hospira, Inc.,
Cook Group Incorporated,
more...
(FDA Code:
GCD /
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.
Advanced Bionics Corporation,
KCK Medical,
Autosuture,
more...
Specialty Blades, Inc.
(FDA Code:
GCC /
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.
Advanced Bionics Corporation,
R-Group International,
KLS Martin, L.P.,
more...
Catheter free pH monitoring system is a catheter-free way to measure pH. It is used to measure esophageal pH (acidity) levels in patients who have or are suspected of having gastro esophageal reflux disease. This system involves a pH capsule, about the size of a gel cap that is temporarily attached to the wall of the esophagus. The pH Capsule measures pH levels in the esophagus and transmits readings via radio telemetry to the receiver worn on the patient's belt or waistband.
RedTech, Inc.,
Medtronic, Inc.,
Raytel Medical Corporation,
more...
(FDA Code:
GCB /
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.
Angiotech Pharmaceuticals, Inc.,
ISPG,
Marina Medical Instruments Inc.,
more...
Medtronic Xomed Surgical Products, Inc