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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Wireless Foot Control
DENTSPLY SIRONA ORTHODONTICS INC.
6659556G
Not in Commercial Distribution

  • D8076659556G1 ()
6659556G

  • Dental diode laser system
MultiTip 8mm, therapy light guide
DENTSPLY SIRONA ORTHODONTICS INC.
6659309G
Not in Commercial Distribution

  • D8076659309G1 ()
6659309G

  • Dental diode laser system
EasyTip Endo Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659291G
Not in Commercial Distribution

  • D8076659291G1 ()
  • D8076659291G0 ()
6659291G

  • Dental diode laser system
EasyTip 320 Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659283G
Not in Commercial Distribution

  • D8076659283G1 ()
  • D8076659283G0 ()
6659283G

  • Dental diode laser system
Laser protective goggle for patient
DENTSPLY SIRONA ORTHODONTICS INC.
6659242G
Not in Commercial Distribution

  • D8076659242G1 ()
6659242G

  • Dental diode laser system
Laser protective goggles for spectacle wearers
DENTSPLY SIRONA ORTHODONTICS INC.
6659234G
Not in Commercial Distribution

  • D8076659234G1 ()
6659234G

  • Dental diode laser system
Laser protective goggles
DENTSPLY SIRONA ORTHODONTICS INC.
6659226G
Not in Commercial Distribution

  • D8076659226G1 ()
6659226G

  • Dental diode laser system
Fibercutter
DENTSPLY SIRONA ORTHODONTICS INC.
6659218G
Not in Commercial Distribution

  • D8076659218G1 ()
6659218G

  • Dental diode laser system
EasyBend - Bending tool
DENTSPLY SIRONA ORTHODONTICS INC.
6659200G
Not in Commercial Distribution

  • D8076659200G1 ()
6659200G

  • Dental diode laser system
Optic protection cap for handpiece (5 pieces)
DENTSPLY SIRONA ORTHODONTICS INC.
6659192G
Not in Commercial Distribution

  • D8076659192G1 ()
  • D8076659192G0 ()
6659192G

  • Dental diode laser system
Handpiece sleeve with keypad
DENTSPLY SIRONA ORTHODONTICS INC.
6659184G
Not in Commercial Distribution

  • D8076659184G1 ()
6659184G

  • Dental diode laser system
Sculpt I.Q. Laser, USA
DENTSPLY SIRONA ORTHODONTICS INC.
6659101G
Not in Commercial Distribution

  • D8076659101G1 ()
6659101G

  • Dental diode laser system
No Description
Therabody, Inc.
TheraFace Hot & Cold Rings White
In Commercial Distribution

  • 00810036056809 ()


  • Electric pad localized-body heating system
  • Hot/cold therapy pack, reusable
No Description
Therabody, Inc.
TheraFace Hot & Cold Rings Black
In Commercial Distribution

  • 00810036056762 ()


  • Electric pad localized-body heating system
  • Hot/cold therapy pack, reusable
Diode 755nm Alex Applicator for Soprano Titanium (Black)
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110123526 ()
AASP28012401

  • Dermatological diode laser system
The Alma Lasers Soprano Titanium Laser System consists of: •System console (contains the laser diodes, the system software, power supply, andvarious other electronic and mechanical parts) •Operator control panel with touch-screen technology (GUI) •Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously Premarket Notification Traditional 510(k) Section 8: Page 2 of 4 Alma Lasers Soprano Titanium • 810 nm applicator • 755 nm applicator • Small NIR applicator • Footswitch and other laser safety accessories
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121829 ()
AASP05091845BSR0001

  • Dermatological diode laser system
  • Intense pulsed light skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121812 ()
AASP30111208

  • Dermatological diode laser system
  • Intense pulsed light skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121676 ()
AAIR02031605

  • Multi-modality skin surface treatment system
Nir Face (6) HP for Soprano Ice Platinum Edition\Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121669 ()
AAIR02031604

  • Multi-modality skin surface treatment system
Diode 810nm Speed 2cm HP for Soprano Ice Platinum Edition / Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121652 ()
AASP30111205

  • Dermatological diode laser system
Diode 755nm Alex 1.5cm HP for Soprano Ice Platinum Edition/Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121645 ()
AASP02031603

  • Dermatological diode laser system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121638 ()
AASP02031602

  • Dermatological diode laser system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121621 ()
AASP02031601

  • Dermatological diode laser system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121614 ()
AASR11021407

  • Radio-frequency skin/body contouring system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121607 ()
AASR11021401

  • Radio-frequency skin/body contouring system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121591 ()
AASP13091303

  • Multi-modality skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121492 ()
AASP18021504WR0001

  • Multi-modality skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121416 ()
AASP14021601BGA0001

  • Multi-modality skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121409 ()
AASP10121401

  • Multi-modality skin surface treatment system
An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
HOME SKINOVATIONS LTD
Solio Alfa +
In Commercial Distribution

  • 07290017992006 ()
  • 17290017992003 ()
  • 27290017992000 ()
7290017992006

  • Medium-wave diathermy treatment system generator
An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
HOME SKINOVATIONS LTD
Relief International
In Commercial Distribution

  • 07290016627138 ()
  • 27290016627132 ()
  • 17290016627135 ()
7290016627138

  • Medium-wave diathermy treatment system generator
An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
HOME SKINOVATIONS LTD
Relief / HeatLux Pro II
In Commercial Distribution

  • 17290015418901 ()
  • 07290015418904 ()
  • 27290015418908 ()
7290015418904

  • Medium-wave diathermy treatment system generator
Icoone Laser Body (also referred to as Icoone body laser) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 611BC14) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (10mW) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
Icoone laser body (also referred to as Icoone body laser)
In Commercial Distribution

  • 18057592610369 ()

  • Pressure: 20 KiloPascal
611BC14

  • Freestanding electric massager
Icoone Laser (also referred to as Icoone Beauty Laser) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 610BEC04) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (10mW) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
Icoone Laser (also referred to as Icoone beauty laser)
In Commercial Distribution

  • 18057592610307 ()

  • Pressure: 20 KiloPascal
610BC04

  • Freestanding electric massager
Icoone Medical Laser (also referred to as Icoone Lase med) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 650EC24) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (1W) Through the display, the light sources can be fully deactivated, or both activated, or only LED activated. The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
ICOONE Laser Med (also called ICOONE MEDICAL LASER)
In Commercial Distribution

  • 18057592610277 ()

  • Pressure: 20 KiloPascal
650EC24

  • Freestanding electric massager
Icoone h (also referred to as Icoone LASER and icoone-h LASER) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone h (also referred to as Icoone LASER and icoone-h LASER) model ref 601EC14 is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (1W) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
In Commercial Distribution

  • 18057592610246 ()

  • Pressure: 20 KiloPascal
601EC14

  • Freestanding electric massager
Laser System
IPG Medical Corporation
MD2300F-001534
In Commercial Distribution

  • 00810071230530 ()


  • General/multiple surgical diode laser system
  • Musculoskeletal/physical therapy laser, professional
Regenalase Therapy Kit, Regenalase Photobiomodulation (PBM) Kit
IPG Medical Corporation
MD2300F-001518
In Commercial Distribution

  • 00810071230516 ()


  • General/multiple surgical diode laser system
  • Musculoskeletal/physical therapy laser, professional
Laser System
IPG Medical Corporation
MD2300F-001780
In Commercial Distribution

  • 00810071230509 ()


  • General/multiple surgical diode laser system
  • Musculoskeletal/physical therapy laser, professional
ST Single Use Tip
VIORA LTD
AS47010
In Commercial Distribution

  • 07290016746440 ()
  • 07290016746433 ()
AS47010

  • Radio-frequency skin/body contouring system
BodyFX
INMODE M.D LTD
AS600874A
In Commercial Distribution

  • 07290016633085 ()
AS600874A

  • Radio-frequency skin surface treatment system
No Description
Therabody, Inc.
RecoveryTherm Hot/Cold/Vibration Knee
In Commercial Distribution

  • 00810036059732 ()


  • Hand-held electric massager
  • Electric pad localized-body heating system
  • Hot/cold therapy pack, reusable
No Description
W.O.M. World of Medicine GmbH
INSFHTDTUB
In Commercial Distribution

  • 04056702008789 ()
  • 04056702008772 ()


  • Endoscopic insufflation tubing set, single-use
No Description
W.O.M. World of Medicine GmbH
Z0260
In Commercial Distribution

  • 04056702007379 ()
  • 04056702007386 ()


  • Endoscopic insufflation tubing set, single-use
No Description
W.O.M. World of Medicine GmbH
Z0260
In Commercial Distribution

  • 04056702002831 ()


  • Endoscopic insufflation tubing set, single-use
MOBILE EXTREMITY WHIRLPOOL, EG26
Whitehall Manufacturing Co
E15MEG26
In Commercial Distribution

  • 00645724004547 ()
E-15-M-EG26

  • Hydrotherapy bath/tank
Bath System - Primo Ferro, Sys23, Hydrosound
Arjohuntleigh AB
AS33311-US
In Commercial Distribution

  • 05055982744867 ()


  • Hydrotherapy bath/tank
Bath System - Ferro Sys23 HS P220 Disp Des
Arjohuntleigh AB
AS33212US0010
In Commercial Distribution

  • 05055982739016 ()


  • Hydrotherapy bath/tank
Bath System - Ferro Sys23 HS P220 Disp Des
Arjohuntleigh AB
AS33212US0001
In Commercial Distribution

  • 05055982739009 ()


  • Hydrotherapy bath/tank
Bath System - Ferro Sys23 HS P220 Disp Des
Arjohuntleigh AB
AS33212US0000
In Commercial Distribution

  • 05055982738996 ()


  • Hydrotherapy bath/tank
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