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

Dentemp SleepTight in an OTC anti-snoring mouthpiece intended for use by adults as an aid to reduce snoring.
Doc Brands, Inc.
1
In Commercial Distribution

  • 00372494103452 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital and perioral wrinkles.
Tanda Beauty Canada, Inc
HU-FG01751
In Commercial Distribution

  • 00806248007296 ()


  • Cosmetic red-light phototherapy system, home-use
Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital and perioral wrinkles.
Tanda Beauty Canada, Inc
HU-CO00621
In Commercial Distribution

  • 10806248006333 ()
  • 00806248006336 ()
HU-CO00621

  • Cosmetic red-light phototherapy system, home-use
Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital and perioral wrinkles.
Tanda Beauty Canada, Inc
HU-FG00851US
In Commercial Distribution

  • 10806248005329 ()
  • 00806248005322 ()
HU-FG00851US

  • Cosmetic red-light phototherapy system, home-use
The HP Hearing PRO self-fitting air conduction hearing aid for Over-the-Counter (OTC) sale to consumers in the new OTC product classification QUH. HP Hearing PRO OTC hearing aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user’s hearing needs. No pre-programming or hearing test is necessary.
NUHEARA LIMITED
NU320-02
In Commercial Distribution

  • 00850000562004 ()


  • Air-conduction hearing aid, in-the-ear
TULIP-ONE SIZE (12MM)/991013-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991013-SWH
In Commercial Distribution

  • 00850016231314 ()


  • Earmould, preformed
The LED Eye mask (Model: A20) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
A20
In Commercial Distribution

  • 00628176949581 ()


  • Cosmetic red-light phototherapy system, home-use
The LED Eye Perfector (Model: EY-36A) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-36A
In Commercial Distribution

  • 00655729008266 ()


  • Cosmetic red-light phototherapy system, home-use
Tens 7000 OTC Electrodes, White Cloth, Mixed 32/pk Includes (16) 2" x 2" square electrodes and (16) 2" x 4" rectangle electrodes
COMPASS HEALTH BRANDS CORP.
DT7202-ELEC204032
In Commercial Distribution

  • 00092237622162 ()
  • 30092237622163 ()
  • 80092237622168 ()
  • 01092237622161 ()


  • Transcutaneous electrical stimulation electrode, single-use
STATCUP II 12 Panel OTC Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 1 test per box
MICRO DISTRIBUTING, L.C
STATII-71127-0-OTC
In Commercial Distribution

  • 00816036025418 ()
STATII-71127-0-OTC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
< 1 ... 79 80 81 82 83 ... 102 >