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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

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LessRay Array, Left
Nuvasive, Inc.
8230009
In Commercial Distribution

  • 00887517756688 ()


  • Diagnostic x-ray digital imaging system workstation
The FFRangio System is a non invasive image based software device
CATHWORKS LTD
FAU04000
In Commercial Distribution

  • 17290017855056 ()
  • 07290017855059 ()
FAU04000

  • Diagnostic x-ray digital imaging system workstation
The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-‎based software ‎device that provides physicians with a quantitative analysis of ‎functional significance of a coronary ‎lesion, similar to invasive FFR (Fractional Flow ‎Reserve), and a qualitative three-dimensional model of ‎the demonstrated coronary ‎arteries, during routine PCI procedure. The FFRangio™ System performs ‎all required ‎processing and calculations based only on angiography images and hemodynamics ‎‎information that are acquired during the coronary catheterization procedure.‎
CATHWORKS LTD
FAU01000
In Commercial Distribution

  • 17290017855025 ()
  • 07290017855028 ()
FAU01000

  • Diagnostic x-ray digital imaging system workstation
No Description
BARDY DIAGNOSTICS, INC.
B1000R7000
In Commercial Distribution

  • 20851398007010 ()


  • Electrocardiographic ambulatory recorder
No Description
BARDY DIAGNOSTICS, INC.
B1000R1400
In Commercial Distribution

  • 40851398007014 ()


  • Electrocardiographic ambulatory recorder
Red and blue light therapy device to reduce the appearance of fine lines and wrinkles and treat mild to moderate acne vulgaris.
CAPILLUS, LLC
AST-804
Not in Commercial Distribution

  • 00810045461427 ()


  • Red/blue light phototherapy unit
3.5mm Syndesmotic Drill, Non-sterile
ARTHREX, INC.
IN0066
Not in Commercial Distribution

  • 00816988010326 ()
IN0066

  • Patient monitoring system module, printing
No Description
BARDY DIAGNOSTICS, INC.
B1000R2000
In Commercial Distribution

  • 30851398007017 ()


  • Electrocardiographic ambulatory recorder
KIT,HOOK-UP,CASE OF 20,ARIA
SPACELABS HEALTHCARE (WASHINGTON), INC
ARIA; SUPPLY
In Commercial Distribution

  • 30841522123041 ()
23189-106-401

  • Electrocardiographic ambulatory recorder
LessRay Monitor & Bracket, 15.6" Touch
Nuvasive, Inc.
8230007
In Commercial Distribution

  • 00887517732729 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Monitor and Bracket, 27"
Nuvasive, Inc.
8230006
In Commercial Distribution

  • 00887517732712 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Cart
Nuvasive, Inc.
8230002
In Commercial Distribution

  • 00887517732675 ()


  • Diagnostic x-ray digital imaging system workstation
MiVu Balloon
DIVERSATEK HEALTHCARE, INC.
MI-BAL-01
In Commercial Distribution

  • 00816734022481 ()

  • Balloon Diameter: 20 Millimeter
MI-BAL-01

  • Manometric gastrointestinal motility analysis system
Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue.
BRONCUS MEDICAL INC.
40009
In Commercial Distribution

  • 00856571007104 ()
40009

  • Virtual bronchoscopic navigation PACS software
SureSigns VS2+ NBP/SP02/Wireless
Philips Medical Systems Hsg
863279
In Commercial Distribution

  • 00884838028401 ()
863279

  • General-purpose multi-parameter bedside monitor
Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest.
Infervision US Inc
2.1.2.1
In Commercial Distribution

  • 00850003095004 ()


  • X-ray image interpretive software
  • Diagnostic x-ray digital imaging system workstation
AUDIOMETER. Piccolo Basic is a portable audiometer that can be controlled from a Windows computer. Available exams: pure tone audiometry via air conduction.
INVENTIS SRL
PICCOLO BASIC
In Commercial Distribution

  • 08054187380341 ()
10327

  • Tone audiometer, manual
Medical device cart to hold an Endoscopy system including, but not limited to : Endoscope, Display, Video processor, Printer, Insufflator, Irrigator, Insulation transformer & Computer.
CGC Technologies Inc
720
In Commercial Distribution

  • 10628678604077 ()
  • 00628678604070 ()
MED-FB4ISSEHC

  • Electromechanical device/system transport trolley
No Description
ST. JUDE MEDICAL, INC.
Xpress Cable
In Commercial Distribution

  • 05414734054157 ()
C12784

  • Medical networking interface unit
Signal Transceiver
ST. JUDE MEDICAL, INC.
AO Transmitter
In Commercial Distribution

  • 05414734054140 ()
C12783

  • Medical networking interface unit
No Description
DIERS International GmbH
0.5
In Commercial Distribution

  • 04260242060071 ()


  • Body-surface pressure mapping system
INFOSEND GSM - North America
FISHER & PAYKEL HEALTHCARE LIMITED
900ICON500N
In Commercial Distribution

  • 09420012425218 ()
900ICON500N

  • Medical networking interface unit
Grael cradle assembly
COMPUMEDICS LIMITED
Grael Cradle
In Commercial Distribution

  • 09342451001245 ()
8028-0003-01

  • Medical networking interface unit
Digital intraoral cameraDigital intraoral camera
GENDEX CORP.
1.007.1970
In Commercial Distribution

  • EKAV100719700 ()
120 0209G1

  • Multi-purpose digital medical camera
Digital intraoral camera
DEXIS LLC
1.007.1969
In Commercial Distribution

  • EKAV100719690 ()
PLU791

  • Multi-purpose digital medical camera
Digital intraoral camera
DEXIS LLC
1.007.1333
In Commercial Distribution

  • EKAV100713330 ()
PLU790

  • Multi-purpose digital medical camera
Digital intraoral camera
GENDEX CORP.
0.822.4331
In Commercial Distribution

  • EKAV082243310 ()
GXC300

  • Multi-purpose digital medical camera
The Canary Home Base Station (Bluetooth) subsystem is a unit with embedded firmware that facilitate communication with CTE and CSE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Canary Medical USA LLC
43-5570-001-15
In Commercial Distribution

  • 00850015699153 ()


  • Medical networking interface unit
PROG-003 Wand
Avertix Medical Inc.
0204-2100-067#P15
In Commercial Distribution

  • 00850012625070 ()
0204-2100-067#P15

  • Implantable cardiac monitor programmer/transmitter/alarm
EXD Lanyard
Avertix Medical Inc.
0203-2100-003
In Commercial Distribution

  • 00850012625056 ()
0203-2100-003

  • Implantable cardiac monitor programmer/transmitter/alarm
EXD Carrying Case
Avertix Medical Inc.
0203-2100-004
In Commercial Distribution

  • 00850012625049 ()
0203-2100-004

  • Implantable cardiac monitor programmer/transmitter/alarm
EXD-001 Kit (Latin-American Spanish)
Avertix Medical Inc.
0203-2100-002-C4#P16
In Commercial Distribution

  • 00850012625032 ()
0203-2100-002-C4#P16

  • Implantable cardiac monitor programmer/transmitter/alarm
EXD-001 Kit
Avertix Medical Inc.
0203-2100-002#P16
In Commercial Distribution

  • 00850012625025 ()
0203-2100-002#P16

  • Implantable cardiac monitor programmer/transmitter/alarm
The Ethernet Switch is a fully managed switch designed for high-performance networking in enterprise environments.
NEURALYNX, INC.
Ethernet Switch
In Commercial Distribution

  • 00850011306253 ()
31-0604-0139

  • Medical networking interface unit
The Beacon transponder is a wireless device composed of an internal circuit and encapsulation materials. The internal circuit resonates in response to an external AC magnetic field. The resonance signal is used to measure the location of the transponders by the Calypso System. The Surface Beacon transponder is comprised of two Beacon transponders. The Surface Beacon transponder in its final packaged state is known as the Beacon Care Package - Surface.
VARIAN MEDICAL SYSTEMS, INC.
ASM0485-000
In Commercial Distribution

  • 00850011006016 ()
ASM0485-000

  • Real-time position management respiratory gating system, optical
Bertec Vision Advantage (BVA) device is designed to measure changes in the visual acuity during head movements. It includes a laptop computer with a wireless remote controller, a wireless inertial measurement unit (IMU) that measures the 3-dimensional angles, velocities, and accelerations, and a headband. The headband holds the IMU in a small pouch, which allows tracking of the head movements. The remote controller is used to input the patient’s responses to the computer.
BERTEC CORPORATION
97P-0037
In Commercial Distribution

  • 00850017250000 ()


  • Dynamic visual acuity testing system
1 Shot Phantom Plus is used for quality control of digital Radiography systems.
FUJIFILM CORPORATION
FCR 1SHOT PHANTOM PLUS MDR E
In Commercial Distribution

  • 04547410538861 ()


  • General-purpose diagnostic x-ray phantom, test object
The Orpyx Hub is the bluetooth-cellular bridge that enables sensor data from the insole to be sent to the cloud as part of the Orpyx Customer Sensory Insole System. This package contains a replacement Orpyx Hub and product documentation such as a manual. The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression. The Orpyx Custom Sensory Insole system is intended to act as an adjunct to standard footcare, not a replacement. It is designed for use throughout everyday activities. Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices.
Orpyx
OH000010
In Commercial Distribution

  • 10185571000554 ()


  • Medical networking interface unit
External Patient Activator
ST. JUDE MEDICAL, INC.
DM2100A
In Commercial Distribution

  • 05414734502696 ()
DM2100A

  • Implantable cardiac monitor programmer/transmitter/alarm
Control Module, Active Breathing Coordinator
ELEKTA LIMITED
1528859
In Commercial Distribution

  • 05060191071284 ()


  • Real-time position management respiratory gating system, optical
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