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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No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06976459491796 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06976459491789 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06977132540381 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06977132540374 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06976459499495 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06976459497200 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06976459497194 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06976459497187 ()


  • Dental appliance fabrication material, ceramic
No Description
Aidite (Qinhuangdao) Technology Co., Ltd.
AT
In Commercial Distribution

  • 06976459493646 ()


  • Dental appliance fabrication material, ceramic
Uric Acid Test Strip
FORA CARE INC.
6 Connect/Test N'GO Advance/Test N'GO Advance Voice
In Commercial Distribution

  • 80816042015256 ()
  • 00816042015250 ()


  • Uric acid IVD, reagent
ADULT POLYCARBONATE ANTERIOR KIT CONTAINING 1OZ ACRYLIC LIQUID, 1OZ ACRYLIC POWDER AND 56 CROWN SHELLS SIZES 1-8 TRANSLUCENT
DIRECT CROWN PRODUCTS
AT
In Commercial Distribution

  • D752AT3 ()
  • D752AT ()


  • Dental bridge, polymer
The Defender Room Air Cleaner ("Defender") is a portable, mechanical air filtration system designed for single use int he home environment. It is configured as a circular unit with a protective outer housing, a pleated fiberglass filter that exceeds HEPA filters in both efficiency and particulate size, and an oxygen activated charcoal filter (HEGA) to remove gasses and odors. During operation, air is drawn into the lower assembly, passes through the upper assembly providing a 360-degree flow of air. The unit is equipped with a scent generator powered by a small heating element. Outlet filtered air passes through the scent generator and out from the top of the unit. The Defender is intended to filter indoor air to remove micro-particles as small as 0.1 micron in size. Including dust, pollen, smoke, dust mites allergens, cockroach allergens, bacteria, mold and pet allergens. The Defender is also intended to remove Tobacco smoke and other household odors.
Health Mor At Home Cbp
D11NA
In Commercial Distribution

  • 00863342000318 ()


  • High-efficiency filter air cleaner, mobile
No Description
AL-BAD MASSUOT YITZHAK LTD
BUSAESCSR20
Not in Commercial Distribution

  • 10075289002066 ()
  • 00075289002069 ()
  • 00834533001728 ()

  • Absorbency


  • Absorbent underpad, non-antimicrobial, single-use
No Description
AL-BAD MASSUOT YITZHAK LTD
BUSAESUWS14
Not in Commercial Distribution

  • 10075289623568 ()
  • 00075289623561 ()
  • 00834533001766 ()

  • Absorbency


  • Incontinence pants, single-use
No Description
AL-BAD MASSUOT YITZHAK LTD
BUSAESUWS20
Not in Commercial Distribution

  • 10075289621922 ()
  • 00075289621925 ()
  • 00834533001759 ()

  • Absorbency


  • Incontinence pants, single-use
No Description
AL-BAD MASSUOT YITZHAK LTD
BUSAESUWS18
Not in Commercial Distribution

  • 10075289621717 ()
  • 00075289621710 ()
  • 00834533001742 ()

  • Absorbency


  • Incontinence pants, single-use
The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in histology laboratories.
Pathcom Systems Corporation
SS1-N
In Commercial Distribution

  • G225SS1N0 ()


  • Microscope slide stainer IVD
Reusable Extension Cable
Oscor Inc.
ATAR-AT
Not in Commercial Distribution

  • 00836559006169 ()

  • Length: 250 Centimeter
ATAR-AT

  • Pacing/defibrillation lead electrical adaptor
At Home, Power Neb
Drive Devilbiss Healthcare
18081-ATHOME
Not in Commercial Distribution

  • 10822383542895 ()
  • 00822383542898 ()


  • Benchtop nebulizer, non-heated
The devices of Fotona LightWalker Laser System Family are based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.
FOTONA d.o.o.
M021-5AF/1
In Commercial Distribution

  • 03830054237629 ()


  • Dental solid-state laser system
  • Dermatological solid-state laser system
  • Multi-modality skin surface treatment system generator
  • General/multiple surgical solid-state laser system
The devices of Fotona LightWalker Laser System Family are based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.
FOTONA d.o.o.
M021-5AF/1
Not in Commercial Distribution

  • 03830054230507 ()


  • Dental solid-state laser system
  • Dermatological solid-state laser system
  • Multi-modality skin surface treatment system generator
  • General/multiple surgical solid-state laser system
The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
FOTONA d.o.o.
M021-5AF/1
Not in Commercial Distribution

  • 03830054230194 ()


  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
  • Dental solid-state laser system
he AT 030 is an appliance that serves to measure intraocular pressure, according to the Goldman method. Assessment of IOP may contribute to the diagnosis, and aid in the management of glaucoma.
Carl Zeiss Meditec AG
AT 030
In Commercial Distribution

  • 04049471090260 ()


  • Ophthalmic examination slit lamp
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
E
In Commercial Distribution

  • 10810190010171 ()
at555200tr

  • Arthroscopic surgical procedure kit, non-medicated, reusable
No Description
AL-BAD MASSUOT YITZHAK LTD
BCNAEZCSR02
Not in Commercial Distribution

  • 00834533001490 ()
  • 00834533000592 ()
  • 10834533000599 ()

  • Absorbency


  • Absorbent underpad, non-antimicrobial, single-use
No Description
Slow Wave, Inc.
AT
In Commercial Distribution

  • 00860007686610 ()
SWAT01

  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
Mouthpiece
S D I DIAGNOSTICS INC
AT
In Commercial Distribution

  • B279S29807020002 ()
  • B279S298070200 ()
29-8070-200

  • Breathing mouthpiece, single-use
Mouthpiece
S D I DIAGNOSTICS INC
AT
In Commercial Distribution

  • B279S29807005001 ()
  • B279S298070050 ()
29-8070-050

  • Breathing mouthpiece, single-use
Mouthpiece
S D I DIAGNOSTICS INC
AT
In Commercial Distribution

  • B279F037020002 ()
  • B279F0370200 ()
F0370-200

  • Breathing mouthpiece, single-use
Mouthpiece
S D I DIAGNOSTICS INC
AT
In Commercial Distribution

  • B279F037005001 ()
  • B279F0370050 ()
F0370-050

  • Breathing mouthpiece, single-use
Scanbody
MEDENTiKA GmbH
AT 1410-SB
In Commercial Distribution

  • 04251574863386 ()
AT 1410-SB

  • Dental implant abutment analog, intraoral-scanning, single-use
Scanbody
MEDENTiKA GmbH
AT 1400-SB
In Commercial Distribution

  • 04251574863379 ()
AT 1400-SB

  • Dental implant abutment analog, intraoral-scanning, single-use
Laboratory implant
MEDENTiKA GmbH
AT 81-ET
In Commercial Distribution

  • 04251574860088 ()
AT 81-ET

  • Dental implant abutment analog, laboratory
Laboratory implant
MEDENTiKA GmbH
AT 81
In Commercial Distribution

  • 04251574860057 ()
AT 81

  • Dental implant abutment analog, laboratory
Laboratory implant
MEDENTiKA GmbH
AT 80-ET
In Commercial Distribution

  • 04251574860040 ()
AT 80-ET

  • Dental implant abutment analog, laboratory
Laboratory implant
MEDENTiKA GmbH
AT 80
In Commercial Distribution

  • 04251574860019 ()
AT 80

  • Dental implant abutment analog, laboratory
Laboratory implant
MEDENTiKA GmbH
AT 51
In Commercial Distribution

  • 04251574859815 ()
AT 51

  • Dental implant abutment analog, laboratory
Laboratory implant
MEDENTiKA GmbH
AT 50
In Commercial Distribution

  • 04251574859808 ()
AT 50

  • Dental implant abutment analog, laboratory
No Description
FGX INTERNATIONAL INC.
5014788-325.FWG
In Commercial Distribution

  • 00193033595800 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
5014788-275.FWG
In Commercial Distribution

  • 00193033595794 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
5014788-250.FWG
In Commercial Distribution

  • 00193033595787 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
5014788-200.FWG
In Commercial Distribution

  • 00193033595770 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
5014788-175.FWG
In Commercial Distribution

  • 00193033595763 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
5014788-150.FWG
In Commercial Distribution

  • 00193033595756 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
5014788-125.FWG
In Commercial Distribution

  • 00193033595749 ()


  • Prescription spectacles
TENS Therapy Electronic Pulse Stimulator
WALGREEN CO.
MDTS100
In Commercial Distribution

  • 10311917013418 ()
  • 00311917013411 ()


  • Analgesic transcutaneous electrical nerve stimulation system
Walgreens 3 ply Ear Loop Face Mask 3 ct
WALGREEN CO.
255914
In Commercial Distribution

  • 00311917221366 ()
  • 10311917221363 ()
  • 60311917221368 ()


  • Public face mask, single-use
WAG 3-PLY EAR LOOP FACE MASK SMALL 50S
WALGREEN CO.
129810
In Commercial Distribution

  • 00311917221199 ()
  • 10311917221196 ()
  • 60311917221191 ()


  • Public face mask, single-use
WAG 3-PLY EAR LOOP FACE MASK ADULT 50S
WALGREEN CO.
129792
In Commercial Distribution

  • 00311917221182 ()
  • 10311917221189 ()
  • 60311917221184 ()


  • Public face mask, single-use
Fingertip Pulse Oximeter
WALGREEN CO.
MD300CN350R
In Commercial Distribution

  • 00311917220529 ()
  • 10311917220526 ()


  • Pulse oximeter
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