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
ACCUTRON, INC.
34668-3
In Commercial Distribution

  • 00813830022315 ()
34668-3

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34568-6
In Commercial Distribution

  • 00813830022308 ()
34568-6

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34568-5
In Commercial Distribution

  • 00813830022292 ()
34568-5

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34568-4
In Commercial Distribution

  • 00813830022285 ()
34568-4

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34568-3
In Commercial Distribution

  • 00813830022278 ()
34568-3

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34368-6
In Commercial Distribution

  • 00813830022261 ()
34368-6

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34368-5
In Commercial Distribution

  • 00813830022254 ()
34368-5

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34368-4
In Commercial Distribution

  • 00813830022247 ()
34368-4

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34368-3
In Commercial Distribution

  • 00813830022230 ()
34368-3

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34168-3
In Commercial Distribution

  • 00813830022155 ()
34168-3

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
33968-6
In Commercial Distribution

  • 00813830021646 ()
33968-6

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
33968-5
In Commercial Distribution

  • 00813830021639 ()
33968-5

  • Nitrous oxide quick-connect coupling, male
The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q3Z9661B
In Commercial Distribution

  • 00845533000260 ()
Q3Z9661B

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
No Description
ACCUTRON, INC.
27254-FRU
In Commercial Distribution

  • 00813830028225 ()
27254-FRU

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
27253-FRU
In Commercial Distribution

  • 00813830028218 ()
27253-FRU

  • Nitrous oxide quick-connect coupling, male
No Description
CHISON Medical Technologies Co., Ltd.
i3
In Commercial Distribution

  • 06945121409445 ()
  • 06945121409315 ()
  • 06945121409438 ()
  • 06945121409421 ()
  • 06945121409414 ()
  • 06945121409407 ()
  • 06945121409391 ()
  • 06945121409384 ()
  • 06945121409377 ()
  • 06945121409360 ()
  • 06945121409353 ()
  • 06945121409346 ()


  • General-purpose ultrasound imaging system
The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data.
Schiller AG
PB-3000 Var.9, sub-variant: Q
In Commercial Distribution

  • 07613365003475 ()
3.921031

  • Patient monitoring system module, multifunction
The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data.
Schiller AG
PB-3000 Var.8, sub-variant: Q
In Commercial Distribution

  • 07613365003468 ()
3.921030

  • Patient monitoring system module, multifunction
No Description
ACCUTRON, INC.
27958-FRU
In Commercial Distribution

  • 00813830028249 ()
27958-FRU

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
27775-FRU
In Commercial Distribution

  • 00813830028232 ()
27775-FRU

  • Nitrous oxide quick-connect coupling, male
An assortment kit composed of thirty single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
Biolase, Inc.
Epic Q, surgical assortment kit, 30PK
In Commercial Distribution

  • 00647529004647 ()

  • Length: 4 Millimeter
  • Outer Diameter: 400 Micrometer
  • Outer Diameter: 200 Micrometer
  • Outer Diameter: 300 Micrometer
6400258

  • Dental diode laser system
This product can be used to make a very aesthetic retainer called Q C M Retainer W The best feature of this product is that the resin part and the wire part are connected by screws so if the resin part gets dirty or damaged the resin part can be replaced
CHIKAMI MILTEC INC.
RWL-W50
In Commercial Distribution

  • 04570077940326 ()


  • Orthodontic retainer
This product can be used to make a very aesthetic retainer called Q C M Retainer W The best feature of this product is that the resin part and the wire part are connected by screws so if the resin part gets dirty or damaged, the resin part can be replaced.
CHIKAMI MILTEC INC.
RWS-W50
In Commercial Distribution

  • 04570077940302 ()


  • Orthodontic retainer
Cable link, FR3 to CPR meter
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 Cable Link to Q CPR Meter
Not in Commercial Distribution

  • 00884838049949 ()
989803149951

  • Non-rechargeable professional semi-automated external defibrillator
UV - Tanning lamp, Accession # 0920281-000 <CR> Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, info@original-hanau.com, http://www.original-hanau.com <CR> Manufacturer: NARVA G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, info@narva-gle.com, http://www.narva-gle.com
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
Strahler OH M Blue Q 500 S
Not in Commercial Distribution

  • 04054657500402 ()
  • 14054657500409 ()
  • 54054657600404 ()
8003 7198

  • Ultraviolet tanning device
UV - Tanning lamp, Accession # 0920280-000 <CR> <CR> Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, info@original-hanau.com, http://www.original-hanau.com <CR> Manufacturer: NARVA G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, info@narva-gle.com, http://www.narva-gle.com
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
Strahler OH M Blue Q 501 EC
Not in Commercial Distribution

  • 04054657500396 ()
  • 14054657500393 ()
  • 54054657600398 ()
8004 0601

  • Ultraviolet tanning device
UV - Tanning lamp, Accession # 0920279-000 <CR> Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, info@original-hanau.com, http://www.original-hanau.com <CR> Manufacturer: NARVA G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, info@narva-gle.com, http://www.narva-gle.com
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
Strahler OH M Blue Q 500 EC
Not in Commercial Distribution

  • 04054657500389 ()
  • 14054657500386 ()
  • 54054657600381 ()
8003 7208

  • Ultraviolet tanning device
Q Switched Nd: YAG Laser machine (QNHF-01) is laser system which delivers las:er at a wavelength 1064nm or 532nm. It consists of control panelmodule, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel
Beijing Nubway S&T Co., Ltd.
QNHF-01
In Commercial Distribution

  • 06971679500914 ()


  • Dermatological laser beam guiding handpiece
BD Difco™ Salmonella O Antiserum Poly D, 3 mL
BECTON, DICKINSON AND COMPANY
225371
In Commercial Distribution

  • 00382902253716 ()

  • Total Volume: 3 Milliliter
225371

  • Multiple Salmonella species antigen IVD, reagent
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; No power cord; No printer, Q- Stress basic laser transport cart with keyboard tray; AHA 10 wire, 12- lead lead set with 43" leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094323726 ()
QS-6CC-XGAAB

  • Cardiopulmonary stress exercise monitoring system computer
Q Stress Cardiac Stress version 6 with adult and pediatric interpretation , includes current software CD and user manual CD , AM12Q Wired Acquisition Module , Software kit , US Canada power cord , No printer, no transport cart , AHA 10 wire, 12 lead lead set with 43 in leadwires with pinch for AM12Q , Isolation transformer 1000 VA Med Global , Report Export XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263176 ()
QS6-BXXCS

  • Electrocardiographic lead set, reusable
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094308723 ()
QS-6CC-DFCXX

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Turnkey system with configured CPU, no display; UK power cord; No printer, Q- Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12- lead lead set with medi-clips; No isolation transformer ; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263213 ()
QS-6IB-CGEXB

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901007
In Commercial Distribution

  • 00732094318470 ()
QS-6EC-CBEAB

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901007
In Commercial Distribution

  • 00732094318463 ()
QS-6EC-CFEAA

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901007
In Commercial Distribution

  • 00732094318456 ()
QS-6EC-CFEAB

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901007
In Commercial Distribution

  • 00732094318449 ()
QS-6EC-CFEAC

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094318142 ()
QS-6AC-CEBAA

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094318135 ()
QS-6AC-CEBAB

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094318128 ()
QS-6AC-CEBAC

  • Cardiopulmonary stress exercise monitoring system computer
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