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 Aura Wave Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits to the patient using magnetic fields. With an array of interchangeable coils, the system can be used to treat a variety of muscles. The Aura Wave is intended to maintain of encourage a general state of health by: - Massage like benefits to aid in personal relaxation - Like Massage, PEMF can provide relief from anxiety and stress - Provides joint and muscle relief due to strenuous sports and work activity - Benefits total wellness and life rejuvenation
Aura Wellness, LLC
Aura Wave
In Commercial Distribution

  • 00850026680140 ()
APN-00068

  • Deep-tissue electromagnetic stimulation system, home-use
  • Deep-tissue electromagnetic stimulation system, professional
The Aura Pulse Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits to the patient using magnetic fields. With an array of interchangeable coils, the system can be used to treat a variety of muscles. The Aura Pulse is intended to maintain of encourage a general state of health by: - Massage like benefits to aid in personal relaxation - Like Massage, PEMF can provide relief from anxiety and stress - Provides joint and muscle relief due to strenuous sports and work activity - Benefits total wellness and life rejuvenation
Aura Wellness, LLC
Aura Pulse Starter Kit
In Commercial Distribution

  • 00850026680102 ()
APN-00050

  • Deep-tissue electromagnetic stimulation system, professional
The Aura Pulse Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits to the patient using magnetic fields. With an array of interchangeable coils, the system can be used to treat a variety of muscles. The Aura Pulse is intended to maintain of encourage a general state of health by: - Massage like benefits to aid in personal relaxation - Like Massage, PEMF can provide relief from anxiety and stress - Provides joint and muscle relief due to strenuous sports and work activity - Benefits total wellness and life rejuvenation
Aura Wellness, LLC
Aura Pulse
In Commercial Distribution

  • 00850026680096 ()
APN-00062

  • Deep-tissue electromagnetic stimulation system, professional
The Handheld Auto Refractometer uses the infrared fundus reflection phase method to emit a beam of infrared light with a specific wavelength, through the subject's cornea, lens, etc., and finally projected to the eye retina, and then reflected back to the corresponding optical system of the instrument. The image is taken through the image sensor, and the spherical refraction power, cylindrical refraction power and astigmatism axis are calculated after image processing and signal processing, which is used to determine the refractive state of human eyes.
Shenzhen CERTAINN Technology Co., Ltd.
easyRef Pro
In Commercial Distribution

  • 06972039971214 ()


  • Automated ophthalmic refractometer
Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. Premier CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.
MERIDIAN BIOSCIENCE, INC.
618096
In Commercial Distribution

  • 00840733101717 ()
618096

  • Campylobacter jejuni antibody IVD, enzyme immunoassay (EIA)
Kit Contains: (T0E15-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R166) Explorer 5 (R245) Mirror Handle (Cone-Socket) (R283) IPC- Non Coated (R286) G2 Thin Composite (R287) G3 Thin Composite (R363S) 113 Straight Serrated Cord Packer (R375) Mixing Spatula/Applicator (R386) 38-39 Excavator (T040) Tweezers COLLEGE (T046) Articulating Paper Forceps MILLER (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T319) Bur Block (T800) IRIS Scissors, curved
PDT, INC.
R984 Composite & Crown Prep Kit
In Commercial Distribution

  • 00813677024503 ()
R984

  • Suture scissors
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Dental spatula, reusable
  • Dental mirror, reusable
  • Manual non-rotary dental instrument handle
  • Dental restoration carver, amalgam, reusable
  • Gingival retraction cord packing tool
  • Dental irrigation/aspiration syringe
  • Dental excavator, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Structure: composed of optical imaging system, control system and display. Working principle: AUTO REF/KERATOMETER is to use infrared fundus reflex phase method, by launching a specific wavelength beam of infrared light, through the examiner cornea, lens and so on, finally projected onto the retina eyeball, then reflected back to the corresponding optical system, absorb the image by image sensor, after image processing, signal processing, calculate the ball lens diopter, axial column lens dioptre, column mirror, An instrument used to determine the refractive state of the human eye. AUTO REF/KERATOMETER can move in X axis, Y axis and Z axis at the same time, with 3D automatic eye tracking function.
Ningbo Ming Sing Optical R & D Co., Ltd.
ARK-910
In Commercial Distribution

  • 06971821402127 ()


  • Automated ophthalmic refractometer
Kit Includes: (T009D-F) D-Series FlipTop™ Cassette - Fixed Rack 9 (R138) Montana Jack® (R166) 5 Explorer (R195) 12 Probe (R245) Cone Socket Mirror Handle (R286) G2 Thin Composite (R362) 113 Off Angle Cord Packer (R375) Mixing Spatula-Applicator (R386) 38-39 Excavator (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T800) Iris Curved Scissors (11.5cm)
PDT, INC.
R935 PDT Crown & Bridge Kit
In Commercial Distribution

  • 00813677024961 ()
R935

  • Dental restoration carver, amalgam, reusable
  • Dental mirror, reusable
  • Instrument tray, reusable
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Gingival retraction cord packing tool
  • Dental spatula, reusable
  • Dental excavator, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental irrigation/aspiration syringe
  • Suture scissors
Kit Includes: (T009D-L) D-Series FlipTop™ Cassette - LiftOut Rack 9 (R166) 5 Explorer (R245) Cone Socket Mirror Handle (R286) G2 Thin Composite (R287) G3 Thin Composite (R362) 113 Off Angle Cord Packer (R375) Mixing Spatula-Applicator (R386) 38-39 Excavator (R534) IPC-T Gold Line™ (Composite Sculpting System) (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T800) Iris Curved Scissors (11.5cm)
PDT, INC.
R934 PDT Composite & Crown Prep Kit
In Commercial Distribution

  • 00813677024954 ()
R934

  • Dental spatula, reusable
  • Dental mirror, reusable
  • Instrument tray, reusable
  • Suture scissors
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Dental restoration carver, amalgam, reusable
  • Gingival retraction cord packing tool
  • Dental excavator, reusable
  • Dental restoration carver, resin
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental irrigation/aspiration syringe
Kit Includes: T015E-F FlipTop™ Cassette 'E' - Fixed Rack 15 w/Std Divider R138R Montana Jack® Rigid R166 Explorer 5 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) R286 G2 Thin Composite R363S 113 Straight Serrated Cord Packer R375 Mixing Spatula/Applicator R386 38-39 Excavator T050 #5 Front Surface Mirror, Cone-Socket, (15/16') T040 Tweezers COLLEGE T046 Articulating paper forceps MILLER T235 Aspirating Anesthetic Syringe Medium T319 Bur Block T800 IRIS Scissors, curved
PDT, INC.
R980 Crown and Bridge Kit
In Commercial Distribution

  • 00813677024466 ()
R980

  • Dental mirror, reusable
  • Manual dental scaler, reusable
  • Dental restoration carver, amalgam, reusable
  • Instrument tray, reusable
  • Dental surgical probe, reusable
  • Suture scissors
  • Manual non-rotary dental instrument handle
  • Gingival retraction cord packing tool
  • Dental spatula, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental excavator, reusable
  • Dental irrigation/aspiration syringe
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