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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equilibrium® mini Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
722-441-24
In Commercial Distribution

  • J011722441240 ()
  • J011722441241 ()


  • Orthodontic bracket, metal
equilibrium® 2 Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
722-342-24
In Commercial Distribution

  • J011722342240 ()
  • J011722342241 ()


  • Orthodontic bracket, metal
equilibrium® 2 Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
722-341-24
In Commercial Distribution

  • J011722341240 ()
  • J011722341241 ()


  • Orthodontic bracket, metal
discovery® pearl Bracket, - 7° Torque, 0° Angulation for tooth 24, McLaughlin-Bennett-Trevisi** 18
DENTAURUM GmbH & Co.KG
718-702-24
In Commercial Distribution

  • J011718702240 ()


  • Orthodontic bracket, ceramic
equilibrium® mini Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
718-442-24
In Commercial Distribution

  • J011718442240 ()
  • J011718442241 ()


  • Orthodontic bracket, metal
equilibrium® mini Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
718-441-24
In Commercial Distribution

  • J011718441240 ()
  • J011718441241 ()


  • Orthodontic bracket, metal
equilibrium® 2 Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
718-342-24
In Commercial Distribution

  • J011718342240 ()
  • J011718342241 ()


  • Orthodontic bracket, metal
discovery® smart Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
718-941-24
In Commercial Distribution

  • J011718941240 ()
  • J011718941241 ()


  • Orthodontic bracket, metal
discovery® pearl bracket, - 7° Torque, 0° Angulation for tooth 24, Roth 18
DENTAURUM GmbH & Co.KG
718-701-24
In Commercial Distribution

  • J011718701240 ()


  • Orthodontic bracket, ceramic
equilibrium® 2 Bracket with hook, - 7° Torque, 0° Angulation for tooth 24
DENTAURUM GmbH & Co.KG
718-341-24
In Commercial Distribution

  • J011718341240 ()
  • J011718341241 ()


  • Orthodontic bracket, metal
DB BKT MINI MS UL CEN 022 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-2022
In Commercial Distribution

  • 00190746108402 ()
310-2022

  • Orthodontic bracket, metal
DB BKT MINI MS UL CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-2002
In Commercial Distribution

  • 00190746108396 ()
310-2002

  • Orthodontic bracket, metal
DB BKT MINI MS UL CEN 022 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1022
In Commercial Distribution

  • 00190746108389 ()
310-1022

  • Orthodontic bracket, metal
DB BKT MINI MS UL CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1002
In Commercial Distribution

  • 00190746108372 ()
310-1002

  • Orthodontic bracket, metal
DB BKT MINI MS UR CEN 022 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-2021
In Commercial Distribution

  • 00190746108365 ()
310-2021

  • Orthodontic bracket, metal
DB BKT MINI MS UR CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-2001
In Commercial Distribution

  • 00190746108358 ()
310-2001

  • Orthodontic bracket, metal
DB BKT MINI MS UR CEN 022 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1021
In Commercial Distribution

  • 00190746108341 ()
310-1021

  • Orthodontic bracket, metal
DB BKT MINI MS UR CEN 018 T+24 A+3 R=0
AMERICAN ORTHODONTICS CORPORATION
310-1001
In Commercial Distribution

  • 00190746108334 ()
310-1001

  • Orthodontic bracket, metal
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS System
Not in Commercial Distribution

  • 00840682100014 ()
H5014PM

  • Breast ultrasound imaging system
StatStrip Glucose Meter With Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480449936 ()
  • 00385480449939 ()
44993

  • Glucose monitoring system IVD, point-of-care
Nova Max Link with Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
Link
In Commercial Distribution

  • 10385480445853 ()
  • 00385480445856 ()
  • 20385480445850 ()
44585

  • Glucose monitoring system IVD, home-use
Nova Max Plus Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480434369 ()
  • 00385480434362 ()
  • 20385480434366 ()
43436

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
Nova Max Plus Plus Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480434352 ()
  • 00385480434355 ()
  • 20385480434359 ()
43435

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
StatStrip Xpress Glucose Meter and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
Xpress
In Commercial Distribution

  • 10385480434048 ()
  • 00385480434041 ()
43404

  • Glucose monitoring system IVD, point-of-care
StatStrip Glucose Meter With Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480422243 ()
  • 00385480422246 ()
42224

  • Glucose monitoring system IVD, point-of-care
Nova Max Plus Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480458242 ()
  • 00385480458245 ()
  • 20385480458249 ()
45824

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Workstation
In Commercial Distribution

  • 00840682100038 ()
H5014WS

  • Breast ultrasound imaging system
No Description
LIFELINES LIMITED
Trackit 24/0 Kit
In Commercial Distribution

  • 05060275450257 ()
2123B

  • Electroencephalographic ambulatory recorder
Prime Auto QC Cartridge CCS 200 Sample
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480451505 ()
45150

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306461 ()
30646

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306454 ()
30645

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306447 ()
30644

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306430 ()
30643

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE pHOx PLUS/C CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus/c
In Commercial Distribution

  • 00385480278966 ()
  • 00385489278967 ()
27896

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE CRITICAL CARE XPRESS CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution

  • 00385480356381 ()
  • 00385489356382 ()
35638

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE pHOx PLUS L CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus L
In Commercial Distribution

  • 00385480341172 ()
  • 00385489341173 ()
34117

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile pHOx Plus L Controls Auto-Cartridge, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340939 ()
34093

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile pHOx Plus L Controls Auto-Cartridge, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340922 ()
34092

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile pHOx Plus L Controls Auto-Cartridge, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340915 ()
34091

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile pHOx Plus L Controls Auto-Cartridge, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340908 ()
34090

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,330
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239332 ()
23933

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,220
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239325 ()
23932

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,110
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239318 ()
23931

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,75
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239301 ()
23930

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE pHOx/BASIC CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox/basic
In Commercial Distribution

  • 00385480227636 ()
  • 00385489227637 ()
22763

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube
Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 9/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489041 ()
48904

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 6/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489034 ()
48903

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
No Description
Dental Savings Club Inc
Mister-X-#0
In Commercial Distribution

  • D9021002003 ()


  • Dental digital imaging sensor, intraoral
Xenoscope, 0°, 10mm x 36 cm
XENOCOR, INC.
XS-0-1036
In Commercial Distribution

  • 00854490007007 ()
XS-0-1036

  • Rigid video laparoscope
  • Rigid-tip video laparoscope/thoracoscope, reusable
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