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
WESTMED, INC.
9500
In Commercial Distribution

  • 00709078001338 ()
  • 10709078001335 ()


  • Electroacoustical airway secretion-clearing system
A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound device and power supply.
AXIOSONIC, LLC
64-405-0004
In Commercial Distribution

  • 00861681000327 ()


  • Physical therapy ultrasound system
A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound device and power supply.
AXIOSONIC, LLC
64-405-0003
In Commercial Distribution

  • 00861681000303 ()


  • Physical therapy ultrasound system
A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound device and power supply.
AXIOSONIC, LLC
64-405-0005
In Commercial Distribution

  • 00861681000310 ()


  • Physical therapy ultrasound system
Hands-Free Autosound
COMPASS HEALTH BRANDS CORP.
410-200
Not in Commercial Distribution

  • 00853904006322 ()


  • Physical therapy ultrasound system
Therapy Hammer- 2/3 cm Dual ultrasound applicator
COMPASS HEALTH BRANDS CORP.
410-115
Not in Commercial Distribution

  • 00853904006285 ()


  • Physical therapy ultrasound system
Therasound EVO (120V)
COMPASS HEALTH BRANDS CORP.
410-020
Not in Commercial Distribution

  • 00853904006186 ()


  • Physical therapy ultrasound system
Therasound 3 Standard (120V)
COMPASS HEALTH BRANDS CORP.
410-026
Not in Commercial Distribution

  • 00853904006179 ()


  • Physical therapy ultrasound system
Winner EVO-CM2, 220v
COMPASS HEALTH BRANDS CORP.
210-010-220
In Commercial Distribution

  • 00852515007735 ()


  • Physical therapy ultrasound system
THERASOUND EVO 220, THERAPY HAMMER, LASER MODULE, LEAD CORDS, 5CM GELSHOTS & ADAPTORS
COMPASS HEALTH BRANDS CORP.
410-020-220
Not in Commercial Distribution

  • 00852515007162 ()


  • Physical therapy ultrasound system
AUTOSOUND 9.6
COMPASS HEALTH BRANDS CORP.
400-021
In Commercial Distribution

  • 00852515007049 ()


  • Physical therapy ultrasound system
Therasound 3 Standard (220V)
COMPASS HEALTH BRANDS CORP.
410-029
Not in Commercial Distribution

  • 00850958007480 ()


  • Physical therapy ultrasound system
Therasound EVO (220V)
COMPASS HEALTH BRANDS CORP.
410-028
Not in Commercial Distribution

  • 00850958007107 ()


  • Physical therapy ultrasound system
Therasound 3.5P
COMPASS HEALTH BRANDS CORP.
400-020
Not in Commercial Distribution

  • 00850958007084 ()


  • Physical therapy ultrasound system
NEO MODULE ULTRASOUND
DJO, LLC
70002
In Commercial Distribution

  • 00190446165279 ()


  • Physical therapy ultrasound system
The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Therapy Control Module, Treatment Module, Endorectal Probe, and consumable Ablapak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.Imported diagnostic data can be fused with the real time ultrasound image in order to facilitate the targeting of the ablation volume.
EDAP-TMS FRANCE
EDP 900800
Not in Commercial Distribution

  • 03661690000199 ()


  • Physical therapy ultrasound system
The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The Focal One system consists of the following main sub-assemblies: Focal One Control Module, Dynamic Focal Probe, and consumable Focalpak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.Imported diagnostic data can be fused with the real time ultrasound image in order to facilitate the targeting of the ablation volume.
EDAP-TMS FRANCE
TMS 239320
In Commercial Distribution

  • 03661690000052 ()


  • Physical therapy ultrasound system
The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
EDAP-TMS FRANCE
EDP 901400
In Commercial Distribution

  • 03661690000243 ()
EDP 901400

  • Physical therapy ultrasound system
The Dynamic Focal Probe is a primary component of the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via this probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
EDAP-TMS FRANCE
TMS 902081
In Commercial Distribution

  • 03661690000205 ()
TMS 902081

  • Physical therapy ultrasound system
The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Therapy Control Module, Treatment Module, Endorectal Probe, and consumable Ablapak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
EDAP-TMS FRANCE
EDP900800
Not in Commercial Distribution

  • 03661690000144 ()


  • Physical therapy ultrasound system
The Ablatherm Endorectal Probe is a primary component of the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
EDAP-TMS FRANCE
EDP 900900
Not in Commercial Distribution

  • 03661690000076 ()
EDP 900900

  • Physical therapy ultrasound system
The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
EDAP-TMS FRANCE
TMS 239305
Not in Commercial Distribution

  • 03661690000069 ()
TMS 239305

  • Physical therapy ultrasound system
The Ablapak is he single use kit of consumables to support a single patient procedure using the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
EDAP-TMS FRANCE
TMS 227710
Not in Commercial Distribution

  • 03661690000014 ()


  • Physical therapy ultrasound system
The KKT-M2 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.
Optima Health Solutions International Corporation
KKT-M2
In Commercial Distribution

  • B854M20 ()
M2

  • Physical therapy ultrasound system
Therasound 3.5P - Device
COMPASS HEALTH BRANDS CORP.
400-020
Not in Commercial Distribution

  • 00092237901731 ()


  • Physical therapy ultrasound system
Therasound 3 Standard Device Only (120V)
COMPASS HEALTH BRANDS CORP.
410-026
Not in Commercial Distribution

  • 00092237901236 ()
  • 01092237901235 ()


  • Physical therapy ultrasound system
Therasound EVO Device Only (220V)
COMPASS HEALTH BRANDS CORP.
410-028
In Commercial Distribution

  • 00092237901229 ()


  • Physical therapy ultrasound system
THERASOUND Evo Device Only - 120V
COMPASS HEALTH BRANDS CORP.
410-020
In Commercial Distribution

  • 00092237901212 ()


  • Physical therapy ultrasound system
Ultra Cure Pro PLUS
COMPASS HEALTH BRANDS CORP.
DU3038
In Commercial Distribution

  • 80092237618864 ()
  • 00092237618868 ()


  • Physical therapy ultrasound system
DS SoundCare Plus - Prof.
COMPASS HEALTH BRANDS CORP.
DS-ULTRSND
In Commercial Distribution

  • 80092237618727 ()
  • 00092237618721 ()


  • Physical therapy ultrasound system
US 1000 3rd - Portable
COMPASS HEALTH BRANDS CORP.
DU1025
In Commercial Distribution

  • 80092237616808 ()
  • 00092237616802 ()


  • Physical therapy ultrasound system
SoundCare Plus - Professional
COMPASS HEALTH BRANDS CORP.
DQ9275
In Commercial Distribution

  • 80092237616747 ()
  • 00092237616741 ()


  • Physical therapy ultrasound system
5cm Sound Head - 2nd Gen
COMPASS HEALTH BRANDS CORP.
DQ8000W5
Not in Commercial Distribution

  • 80092237616440 ()
  • 00092237616444 ()


  • Physical therapy ultrasound system
1cm Sound Head - 2nd Gen
COMPASS HEALTH BRANDS CORP.
DQ8000W1
Not in Commercial Distribution

  • 80092237616433 ()
  • 00092237616437 ()


  • Physical therapy ultrasound system
UltraTENS II - Ultrasound and
COMPASS HEALTH BRANDS CORP.
DU6012
In Commercial Distribution

  • 80092237611636 ()
  • 00092237611630 ()


  • Physical therapy ultrasound system
LG Pro Series 2nd Edition
COMPASS HEALTH BRANDS CORP.
DU3037
In Commercial Distribution

  • 80092237611568 ()
  • 00092237611562 ()


  • Physical therapy ultrasound system
US Pro 2000 2nd Edition
COMPASS HEALTH BRANDS CORP.
DU3035
In Commercial Distribution

  • 80092237611544 ()
  • 00092237611548 ()


  • Physical therapy ultrasound system
THERASOUND Evo Device with hammer, electrodes, & gel
COMPASS HEALTH BRANDS CORP.
410-020-HMR
In Commercial Distribution

  • 00092237902530 ()


  • Physical therapy ultrasound system
Winner Evo CM2 Device W/ HAMMER, electrodes, gel and lead wires
COMPASS HEALTH BRANDS CORP.
410-010-HMR
In Commercial Distribution

  • 00092237902523 ()


  • Physical therapy ultrasound system
SoundCare Plus - Wand, 5 cm
COMPASS HEALTH BRANDS CORP.
DQ9275W5
In Commercial Distribution

  • 00092237618226 ()


  • Physical therapy ultrasound system
SoundCare Plus - Wand, 1 cm
COMPASS HEALTH BRANDS CORP.
DQ9275W1
In Commercial Distribution

  • 00092237618219 ()


  • Physical therapy ultrasound system
No Description
Dynatronics Corporation
D125B
In Commercial Distribution

  • 10660584000147 ()

  • Weight: 4.0 Pound
  • Height: 4.0 Inch
  • Width: 7 Inch
  • Length: 9.0 Inch


  • Physical therapy ultrasound system
Venus Viva applicator kit: Viva applicator and Viva tips 5 pack, packed in a suitcase.
VENUS CONCEPT LTD
KT120009
In Commercial Distribution

  • 07290016540598 ()


  • Radio-frequency skin contouring system applicator, bipolar
  • Radio-frequency skin contouring system applicator tip
Single Patient Use Filshie® Clip Applicator System. Applicator for use ONLY in Sterishot Kits.
FEMCARE LIMITED
AVM-600
In Commercial Distribution

  • 15055515602326 ()
AVM-600

  • Fallopian tube clip/band
No Description
QUALITY ELECTRODYNAMICS LLC
Q7000225
In Commercial Distribution

  • 00814848020775 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
REFDAUX
In Commercial Distribution

  • 00850011790229 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
RESYS4001
In Commercial Distribution

  • 00850011790168 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
RESYS4001-RESYSAB
In Commercial Distribution

  • 00850011790151 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
REPD2000
In Commercial Distribution

  • 00850011790106 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
REFPDS19
In Commercial Distribution

  • 00850011790052 ()


  • Magnetic resonance elastography acoustic driver
< 1 ... 130 131 132 133 134 ... 200 >