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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Perception Panel
G&J Electronics Inc
PP-01
In Commercial Distribution

  • 00627843670919 ()


  • Gastrointestinal barostat
Gap Panel
Kinamed, Inc.
16-1P3-1045
In Commercial Distribution

  • 00898142001685 ()
16-1P3-1045

  • Cranioplasty plate, alterable
Hex Panel
Kinamed, Inc.
14-1P3-9020
In Commercial Distribution

  • 00898142001180 ()
14-1P3-9020

  • Cranioplasty sheet
Hex Panel
Kinamed, Inc.
14-1P3-9013
In Commercial Distribution

  • 00898142001159 ()
14-1P3-9013

  • Cranioplasty sheet
Gap Panel
Kinamed, Inc.
14-1P3-0886
In Commercial Distribution

  • 00898142001111 ()
14-1P3-0886

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
pink panel
Shenzhen Jumper Medical Equipment Co.,Ltd.
JPD-500A
In Commercial Distribution

  • 06951740522229 ()


  • Pulse oximeter
RSLPP-OS (PREGNANCY PANEL, .5MM STARLITE, PREGNANCY PANEL, OS)
BURLINGTON MEDICAL, LLC
RSLPP-OS
In Commercial Distribution

  • 00840331274363 ()

  • XS Male


  • Radiation shielding apron
Remote Start/Stop
Breas Medical AB
006649
In Commercial Distribution

  • 07321820066490 ()
006649

  • Assistive remote control
Remote Start/Stop
Breas Medical AB
006342
In Commercial Distribution

  • 07321820063420 ()
006342

  • Assistive remote control
No Description
EITAN MEDICAL LTD
15071-000-0005
Not in Commercial Distribution

  • 07290109150031 ()
  • 27290109150035 ()
  • 17290109150038 ()
15071-000-0005

  • Assistive remote control
Reusable non-sterile tangential couchtop panel for use with Nucletron Simulix-HP
MEDTEC, INC.
MTIL3202
Not in Commercial Distribution

  • 00841439104729 ()

  • Width: 21.8 Inch
  • Length: 35.4 Inch
MTIL3202

  • Indexed-immobilization patient positioning system
For use with Varian Exact™ system
MEDTEC, INC.
MTIL3103
Not in Commercial Distribution

  • 00841439104699 ()

  • Width: 20.9 Inch
  • Length: 36.2 Inch
MTIL3103

  • Indexed-immobilization patient positioning system
Posterior panel for Varian ETR
MEDTEC, INC.
MTIL310001
Not in Commercial Distribution

  • 00841439104682 ()

  • Width: 20.9 Inch
  • Length: 47.3 Inch
MTIL310001

  • Indexed-immobilization patient positioning system
Reusable non-sterile solid couchtop panel for use with Siemens ZXT system
MEDTEC, INC.
MTIL301003
Not in Commercial Distribution

  • 00841439104576 ()

  • Length: 80 Centimeter
  • Width: 53 Centimeter
MTIL301003

  • Indexed-immobilization patient positioning system
Reusable non-sterile tangental coutchtop panel for use with Siemens ZXT system
MEDTEC, INC.
MTIL301002
Not in Commercial Distribution

  • 00841439104569 ()

  • Width: 53 Centimeter
  • Length: 80 Centimeter
MTIL301002

  • Indexed-immobilization patient positioning system
Reusable non-sterile grid couchtop panel for use with Siemens ZXT system
MEDTEC, INC.
MTIL301001
Not in Commercial Distribution

  • 00841439104552 ()

  • Length: 80 Centimeter
  • Width: 53 Centimeter
MTIL301001

  • Indexed-immobilization patient positioning system
Reusable non-sterile solid couchtop panel for use with Siemens ZXT system
MEDTEC, INC.
MTIL300512
Not in Commercial Distribution

  • 00841439104491 ()

  • Width: 53 Inch
  • Length: 80 Centimeter
MTIL300512

  • Indexed-immobilization patient positioning system
Grid panel for Calypso 4D Localization System and Siemens ZXT or TXT base
MEDTEC, INC.
20IL430104
Not in Commercial Distribution

  • 00841439102114 ()

  • Length: 78.2 Centimeter
  • Width: 53 Centimeter
20IL430104

  • Indexed-immobilization patient positioning system
Grid panel for Calypso 4D Localization System and Varian Exact base
MEDTEC, INC.
20IL430003
Not in Commercial Distribution

  • 00841439102053 ()

  • Width: 53 Centimeter
  • Length: 89.9 Centimeter
20IL430003

  • Indexed-immobilization patient positioning system
Electro-Mesh Panel 4x8
PRIZM MEDICAL, INC.
EMSP48
In Commercial Distribution

  • B872EMSP480 ()


  • Transcutaneous electrical stimulation electrode, single-use
Electro-Mesh Panel 4x4
PRIZM MEDICAL, INC.
EMSP44
In Commercial Distribution

  • B872EMSP440 ()


  • Transcutaneous electrical stimulation electrode, single-use
Electro-Mesh Panel 1.5x4
PRIZM MEDICAL, INC.
EMSP24
In Commercial Distribution

  • B872EMSP240 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
Aktina Corp.
51-220
In Commercial Distribution

  • B365512200 ()


  • Indexed-immobilization patient positioning system
Reusable non-sterile solid couchtop panel for use with Siemens ZXT or Z4 systems
MEDTEC, INC.
MTZXTZ44069CS
Not in Commercial Distribution

  • 00841439108932 ()

  • Length: 79.4 Centimeter
  • Width: 49.1 Centimeter
MTZXTZ44069CS

  • Indexed-immobilization patient positioning system
Reusable non-sterile grid couchtop panel for use with Siemens ZXT or Z4 systems
MEDTEC, INC.
MTZXTZ44069CF
Not in Commercial Distribution

  • 00841439108925 ()

  • Length: 79.4 Centimeter
MTZXTZ44069CF

  • Indexed-immobilization patient positioning system
No Description
Bracco Injeneering SA
017382
In Commercial Distribution

  • 37630039300419 ()
017382

  • MRI contrast medium injection system, line-powered, mobile
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801083 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Temp Pal can be used at home and healthcare center.
iWEECARE Co., Ltd.
STP-MB01-1
In Commercial Distribution

  • 04712977931060 ()
  • 14712977931067 ()


  • Wireless patient thermometer, reusable
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App Android
In Commercial Distribution

  • 09413000126273 ()


  • Electronic goniometer/kinesiology sensor
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App iOS
In Commercial Distribution

  • 09413000126259 ()


  • Electronic goniometer/kinesiology sensor
Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
DK-017-R
In Commercial Distribution

  • 09413000123418 ()


  • Electronic goniometer/kinesiology sensor
Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
DK-017-L
In Commercial Distribution

  • 09413000123395 ()


  • Electronic goniometer/kinesiology sensor
Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
DK-013
In Commercial Distribution

  • 09413000113839 ()


  • Electronic goniometer/kinesiology sensor
The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
2001-CHG-DOC-US
In Commercial Distribution

  • 09369998000562 ()
  • 09369998308569 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
GKC-2000
In Commercial Distribution

  • 09369998208654 ()
  • 09369998107773 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms such as Parkinson's disease, including tremor, bradykinesia and dyskinesia
GKC MANUFACTURING PTY LTD
GKC-2009
In Commercial Distribution

  • 09369998040162 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
2022-CHG-DOC-UNI
In Commercial Distribution

  • 09359011000327 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The PKG Smart Charger is a portable charging station to be used in conjunction with 2000-LOG-004 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
2022-CHG-DOC-004
In Commercial Distribution

  • 09359011000310 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
2000-LOG-004
In Commercial Distribution

  • 09359011000303 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
2022-CHG-DOC-V1.2
In Commercial Distribution

  • 09359011000297 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
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