Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

Show Filters

No Description
Thought Technology Ltd.
SA9800
In Commercial Distribution

  • 07540191000104 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
No Description
Thought Technology Ltd.
SA9000
In Commercial Distribution

  • 07540191000555 ()


  • Psychophysiological biofeedback system
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Perineal orifice incontinence-control electrical stimulation system, professional
No Description
Thought Technology Ltd.
SA9013
In Commercial Distribution

  • 07540191000548 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
No Description
Thought Technology Ltd.
SA9572
In Commercial Distribution

  • 07540191000418 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Perineal orifice incontinence-control electrical stimulation system, professional
  • Psychophysiological biofeedback system
No Description
Thought Technology Ltd.
SA9571
In Commercial Distribution

  • 07540191000401 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
No Description
Clinical Laserthermia Systems AB
L-2019-062
In Commercial Distribution

  • 17340007000871 ()


  • General/multiple surgical diode laser system
  • MRI system application software
  • General/multiple surgical laser system beam guide, reusable
One-Piece Flat Calf Panel Mount Assy designed for use with Motion Concepts CM Legrests (includes mounting hardware). One-Piece Calf Pad sold separately. Available in a variety of widths and heights to accommodate different user needs.
Motion Concepts Inc
D-0101-0157-OSCPL
In Commercial Distribution

  • 07540147002473 ()
OSCPL

  • Wheelchair footrest/legrest
  • Wheelchair legrest pad
Extended Mounting Pins (4pcs). Hardware for Matrx Elite, E2 Backs (18H/20H) and PB Backs. Extended pins allow mounting onto back canes up to 2" wider than nominal back width (up to 20" back widths).
Motion Concepts Inc
EMP
In Commercial Distribution

  • 07540147000622 ()
EMP

  • Wheelchair back rest positioner pin
Flat Hand Pad. (Molded, skinned polyurethane hand pad designed for use in combination with the Ergonomic Arm Trough (sold separately)). The Flat Hand Pad is compatible with Left or Right Arm Troughs. Mounting hardware is included.
Motion Concepts Inc
D-0153-FHP
In Commercial Distribution

  • 07540147002718 ()
FHP

  • Wheelchair armrest
Fixed Joystick Mount Assembly. Components/hardware used to fix-mount a wheelchair joystick to the armrest on a Motion Concepts Power Positioning System. Straight or jogged tube option available. Can be mounted onto Left or Right armrests.
Motion Concepts Inc
D-0181-FJ
In Commercial Distribution

  • 07540147001971 ()
FJ

  • Wheelchair bracket/mount
54 Unit Mining First Aid Kit - Contains: Adhesive Plastic Bandages, 1" x 3", 16 ct; Aluminized Rescue Blanket, 52" x 84"; Ammonia Inhalants, 20 ct; First Aid Guide; First Aid/Burn Cream Packets, 12 ct; Hema-Flex Bandage Compress, 2", 8 ct; Hema-Flex Bandage Compress, 4", 8 ct; Padded Flexible Splint, 4" x 24"; Stretch Tourniquet, 1" x 18", 2 ct; Triangular Bandage, 40" x 40" x 56", 24 ct; Triple Antibiotic Ointment Packets, 12 ct.
Acme United Corporation
90795
In Commercial Distribution

  • 00092265907958 ()
90795

  • First aid kit, medicated
The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.
MEDIPINES CORPORATION
AGM100
In Commercial Distribution

  • 00860001261509 ()
AGM100

  • Multiple vital physiological parameter monitoring system, clinical
  • Respiration monitor
  • Patient monitoring system module, multiple-gas
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
VERDURE IMAGING, INC.
000010
In Commercial Distribution

  • G618000010 ()


  • Ultrasound imaging system operation software
  • Hand-held ultrasound imaging system, body-surface
  • Ultrasound imaging system operator console
No Description
Thought Technology Ltd.
SA9020
In Commercial Distribution

  • 07540191000593 ()


  • Psychophysiological biofeedback system
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Perineal orifice incontinence-control electrical stimulation system probe, reusable
No Description
Thought Technology Ltd.
SA9030
In Commercial Distribution

  • 07540191000586 ()


  • Psychophysiological biofeedback system
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Perineal orifice incontinence-control electrical stimulation system probe, reusable
Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions.
FOCUS SURGERY INC
102-17000-0009
In Commercial Distribution

  • 00868108000212 ()


  • Ultrasonic hyperthermia system
The Halcyon Couch Positioning Plate is an accessory to the 3D SCANNER system that allows the 3D SCANNER Water Tank to be placed and positioned on a Varian Halcyon delivery system couch. The Couch Positioning Plate is indexed to the Halcyon couch and coordinate system; SNC Dosimetry software Autosetup™ has been modified for Halcyon couch measurements using a new, patent-pending leveling technique.
SUN NUCLEAR CORP.
1231410Z
In Commercial Distribution

  • 05060608880201 ()
1231410Z

  • Accelerator system quality assurance device
Desk to Full Armrest Extension Kit. Armrest Extension tube (insert) to allow longer tube lengths for mounting full length arm pads or to allow for greater arm pad depth adjustment. Mounting hardware included. Kit contains one extension tube
Motion Concepts Inc
D-0123-0128-AEXT
In Commercial Distribution

  • 07540147002893 ()
AEXT

  • Wheelchair armrest
Heavy-Duty 70° Swing Away Legrest Set. Set includes 2 upper down tube assemblies and 2 extension tube assemblies. Hardware included. Three extension tube options/sizes available: 11"-15", 13"-17", 16"-20". Footplates and footplate mounts sold separately.
Motion Concepts Inc
D-0130-HD70
In Commercial Distribution

  • 07540147002855 ()
HD70S

  • Wheelchair footrest/legrest
PowerDR Console Application is an X-ray digital imaging system designed for generating high-resolution, full-fidelity digital projection radiographic and fluoroscopic images with an X-ray imaging receptor. The PowerDR Console Application receives imaging exam orders, acquires images from X-Ray detectors or from any DICOM device to process the images to produce real time fluoroscopic image sequences and full fidelity radiographic images for medical diagnostic purposes. The processed and/or received images can be stored in a local or web/cloud based Picture Archive and Communication System (PACS).
Radiology Information Systems, Inc.
PowerDR
In Commercial Distribution

  • 00860009490604 ()


  • Radiology information system application software
  • Diagnostic x-ray digital imaging system workstation
  • Radiology picture archiving and communication system workstation
The Halcyon Bracket is an accessory to the 3D SCANNER system and provides an electrical connection to the 3D SCANNER motors when the 3D SCANNER Water Tank is used with the Varian Halcyon delivery system.
SUN NUCLEAR CORP.
1231405Z
In Commercial Distribution

  • 05060608880195 ()
1231405Z

  • Accelerator system quality assurance device
V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent.
VIATRONIX INCORPORATED
2.1
In Commercial Distribution

  • B209CAS2X10 ()


  • Radiological PACS software
V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent.
VIATRONIX INCORPORATED
2.0
In Commercial Distribution

  • B209CAS2X00 ()


  • Radiological PACS software
Quad-Link Swing-Away Joystick Mount Assembly. Components/hardware used to mount the Quad-Link Swing-Away Joystick assembly onto the armrest on a Motion Concepts Power Positioning System. Straight or jogged tube option available. Can be mounted onto Left or Right armrests.
Motion Concepts Inc
D-0181-SAQ
In Commercial Distribution

  • 07540147001995 ()
SAQ

  • Wheelchair bracket/mount
V3D-Vascular is a software application used with advanced PC hardware for evaluating scanned images of selected vessels. It is designed to aid the physician in analyzing the vascular system based on DICOM 3.0 compliant images from CT or MR scan.
VIATRONIX INCORPORATED
2.0
In Commercial Distribution

  • B209VA2X00 ()


  • Radiological PACS software
Maxx Resolve Swing-Away Joystick Mount Assembly. Components/hardware used to mount the Resolve Swing-Away Joystick assembly onto the armrest on a Motion Concepts Power Positioning System. Straight or jogged tube option available. Can be mounted onto Left or Right armrests
Motion Concepts Inc
D-0181-MR
In Commercial Distribution

  • 07540147001988 ()
MR

  • Wheelchair bracket/mount
The J3 Back now offers a Carbon Fiber shell option for the ultimate in lightweight performance. Weighing as little as 2.2 lbs. when combined with RH hardware, the J3 Carbon Fiber Back is the perfect addition to any Quickie ultra lightweight wheelchair.
SUNRISE MEDICAL (US) LLC
J3 Carbon Back
In Commercial Distribution

  • 00016958056785 ()
Jay

  • Gel-filled chair cushion
Matrx Back Interface Kit includes mounting hardware to affix a Matrx Elite, PB or E2 Back onto a Motion Concepts Power Positioning System with Tilt canes. Must specify the type of Matrx back being installed (Interface kits vary slightly depending on Back model).
Motion Concepts Inc
D-0139-MBIT
In Commercial Distribution

  • 07540147002916 ()
MBIT

  • Wheelchair bracket/mount
  • Wheelchair back rest positioner
Standard Arm Pads (Faux-vinyl cover PU foam arm pads for comfort and durability). Standard Arm Pads are available in Desk length 10" or Full length 14". Mounting hardware included. Depth adjustable Optional wheelchair component for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0153-SAP
In Commercial Distribution

  • 07540147002763 ()
SAP

  • Wheelchair armrest
Ergonomic Arm Trough (Molded, skinned polyurethane arm pad designed to fit the natural arm curvature; elbow cut-out allows for various arm positions) Left and right arm trough configurations available.. Mounting hardware included. Depth and width adjustable. Optional Flat Hand Pad available (sold separately).
Motion Concepts Inc
D-0153-EAT
In Commercial Distribution

  • 07540147002701 ()
EAT

  • Wheelchair armrest
< 1 ... 209 210 211 212 213 ... 223 >