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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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The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
EL GLOBAL TRADE LTD
ST100US01SNS
In Commercial Distribution

  • 05060445341125 ()


  • Radio-frequency skin surface treatment system
The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite
EL GLOBAL TRADE LTD
CEL100US01SNS
In Commercial Distribution

  • 05060445341118 ()


  • Radio-frequency skin surface treatment system
Handheld electronic device which receives temperature sensitive crystal oscillations via near field magnetic link. The oscillation measurement is converted to a temperature using the sensor's calibration number.
H Q, INC
HT150001
In Commercial Distribution

  • 00857414006025 ()


  • Temperature telemetric monitoring system transmitter
MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofluorescent detection procedure for the simultaneous detection of Cryptosporidium oocysts and Giardia cysts in fecal material.
MERIDIAN BIOSCIENCE, INC.
250050
In Commercial Distribution

  • 00840733101113 ()
250050

  • Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT)
EZ Rider models are manual wheelchairs intended to provide mobility to a person with disabilities who is permanently or partially non-ambulatory and limited to a seated position.
CONVAID PRODUCTS, INC.
EZ12
In Commercial Distribution

  • 10840117400068 ()
900860

  • Transport wheelchair, collapsible
  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
  • Attendant-only-propelled wheelchair, non-bariatric
The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander. It brings person from seated position to a passive standing position and have mobility.
MATIA ROBOTICS MEKATRONIK SISTEMLER AR-GE MUHENDISLIK YAZILIM SANAYI VE TICARET A S
01
In Commercial Distribution

  • 08680905006905 ()
TEKRMD01

  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
The VX220 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: keratometer, corneal topographer, tonometer,and pachymeter and retro illumination
LUNEAU TECHNOLOGY OPERATIONS
VX220
In Commercial Distribution

  • 03664188002200 ()


  • Ophthalmic tonometer, battery-operated
  • Optical pachymeter
The VX118 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, pachymeter and retro illumination.
LUNEAU TECHNOLOGY OPERATIONS
VX118
In Commercial Distribution

  • 03664188001180 ()


  • Optical pachymeter
  • Automated ophthalmic refractometer
Tethys H10 is intended only for the washing and/or thermal disinfection of re-usable surgical instruments able to resist to a temperature of at least 80°C.
CEFLA SOCIETA' COOPERATIVA
Tethys H10
In Commercial Distribution

  • 08033837931331 ()
M7E200310

  • Ultrasonic-cleaning water bath
  • Surgical utensil washer/disinfector
The CrossRoads™ Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
15LP-3546
In Commercial Distribution

  • 00815432028887 ()
15LP-3546

  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Fluted surgical drill bit, single-use
  • Orthopaedic bone wire
  • Surgical instrument handle, non-torque-limiting
  • Surgical countersink, single-use
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