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
M & T SRL
Mt one
In Commercial Distribution

  • 08057622080028 ()


  • Dermatological diode laser system
  • Dermatological solid-state laser system
  • Cosmetic red-light phototherapy system, professional
Cap for hair growth, photobiomodulation.
CAPILLUS, LLC
One S
In Commercial Distribution

  • 00810045461014 ()


  • Hair growth laser device
MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One CFD
GE Hualun Medical Systems Co., Ltd
One CFD
In Commercial Distribution

  • 00840682145541 ()


  • Mobile general-purpose fluoroscopic x-ray system, digital
Fluid Warming System Stand - ODM-STN01
ONE DEGREE MEDICAL HOLDINGS, LLC
ODM-STN01
In Commercial Distribution

  • 00860003583067 ()


  • Bowl/basin stand
3.8L Capacity Fluid Warming Unit - ODM-3038
ONE DEGREE MEDICAL HOLDINGS, LLC
ODM-3038
In Commercial Distribution

  • 00860003583050 ()


  • Surgical fluid heating plate
6.6L Capacity Fluid Warming Unit - ODM-3066
ONE DEGREE MEDICAL HOLDINGS, LLC
ODM-3066
In Commercial Distribution

  • 00860003583043 ()


  • Surgical fluid heating plate
Fluid Warmer Drape 44" x 60" (ODM-2066)
ONE DEGREE MEDICAL HOLDINGS, LLC
ODM-2066
In Commercial Distribution

  • 10860003583033 ()
  • 00860003583036 ()


  • Medical equipment/instrument drape, single-use
Fluid Warmer Drape 44" x 60" (ODM-2038)
ONE DEGREE MEDICAL HOLDINGS, LLC
ODM-2038
In Commercial Distribution

  • 10860003583026 ()
  • 00860003583029 ()


  • Medical equipment/instrument drape, single-use
Fluid Warmer Drape 44" x 66" (ODM-1100)
ONE DEGREE MEDICAL HOLDINGS, LLC
ODM-1100
In Commercial Distribution

  • 10860003583019 ()
  • 00860003583012 ()


  • Medical equipment/instrument drape, single-use
Fluid Warmer Drape 44" x 44" (ODM-1000)
ONE DEGREE MEDICAL HOLDINGS, LLC
ODM-1000
In Commercial Distribution

  • 10860003583002 ()
  • 00860003583005 ()


  • Medical equipment/instrument drape, single-use
WatchPAT ONE
ITAMAR MEDICAL LTD
WatchPATONE
In Commercial Distribution

  • 07290109222424 ()
  • 07290109222431 ()
  • 07290109222271 ()
  • 07290109222264 ()
  • 07290109223360 ()
AC2110800

  • Polysomnograph
DISPETTE ONE
Guest Scientific AG
FH1500
Not in Commercial Distribution

  • 07612964013335 ()
  • 07612964013328 ()
  • 07612964013342 ()
FH1500

  • Erythrocyte sedimentation rate (ESR) IVD, kit
DISPETTE ONE
Guest Scientific AG
FH1500
Not in Commercial Distribution

  • 07612964013113 ()
  • 07612964013106 ()
  • 07612964013120 ()
FH1500

  • Erythrocyte sedimentation rate (ESR) IVD, kit
AIRFLOW One
E.M.S. Electro Medical Systems S.A.
FT-230-2B-V02
In Commercial Distribution

  • 07613353214449 ()


  • Dental abrasive air jet system
AIRFLOW One
E.M.S. Electro Medical Systems S.A.
FT-230-2B-302
In Commercial Distribution

  • 07613353213183 ()


  • Dental abrasive air jet system
AIRFLOW One
E.M.S. Electro Medical Systems S.A.
FT-230-0B-302
In Commercial Distribution

  • 07613353209179 ()


  • Dental abrasive air jet system
AIRFLOW One
E.M.S. Electro Medical Systems S.A.
FT-230S-STM2
In Commercial Distribution

  • 07613353195243 ()


  • Dental abrasive air jet system
Vyntus ONE
Jaeger Medical GmbH
V-707960
In Commercial Distribution

  • 04250892905747 ()
V-707960

  • Pulmonary function analysis system, adult
Vyntus ONE
Jaeger Medical GmbH
V-178600-13
In Commercial Distribution

  • 04250892904733 ()
V-178600-13

  • Pulmonary function analysis system, adult
Vyntus ONE
VYAIRE MEDICAL, INC.
V-178604
In Commercial Distribution

  • 04250892904726 ()
V-178604

  • Pulmonary function analysis system, adult
Vyntus ONE
Jaeger Medical GmbH
V-178603
In Commercial Distribution

  • 04250892904719 ()
V-178603

  • Pulmonary function analysis system, adult
Vyntus ONE
Jaeger Medical GmbH
V-178602
In Commercial Distribution

  • 04250892904702 ()
V-178602

  • Pulmonary function analysis system, adult
Vyntus ONE
Jaeger Medical GmbH
V-178601
In Commercial Distribution

  • 04250892904696 ()
V-178601

  • Pulmonary function analysis system, adult
Vyntus ONE
Jaeger Medical GmbH
V-178600-13
Not in Commercial Distribution

  • 04250892902661 ()
V-178600-13

  • Pulmonary function analysis system, adult
Vyntus ONE
Jaeger Medical GmbH
V-178603
Not in Commercial Distribution

  • 04250892902609 ()
V-178603

  • Pulmonary function analysis system, adult
Vyntus ONE
Jaeger Medical GmbH
V-178602
Not in Commercial Distribution

  • 04250892902593 ()
V-178602

  • Pulmonary function analysis system, adult
Vyntus ONE
Jaeger Medical GmbH
V-178601
Not in Commercial Distribution

  • 04250892902586 ()
V-178601

  • Pulmonary function analysis system, adult
Vyntus ONE
Jaeger Medical GmbH
V-178699
In Commercial Distribution

  • 04250892901084 ()
V-178699

  • Pulmonary function analysis system, adult
SONICAID ONE
HUNTLEIGH HEALTHCARE LIMITED
SONICAIDONE
In Commercial Distribution

  • 05051968025265 ()
SONICAIDONE

  • Foetal Doppler system
Dilator One
SPINEOLOGY INC.
67-08-06
In Commercial Distribution

  • M7406710052 ()
671-0052

  • Laparoscopic access cannula dilator
Dilator One
SPINEOLOGY INC.
86-11-33
In Commercial Distribution

  • M7408610054 ()
861-0054

  • Metallic spinal interbody fusion cage
Dilator One
SPINEOLOGY INC.
33-08-02
In Commercial Distribution

  • M7403120014 ()
312-0014

  • Laparoscopic access cannula dilator
Dilator One
SPINEOLOGY INC.
53-07-11
In Commercial Distribution

  • M7405300012 ()
530-0012

  • Laparoscopic access cannula dilator
Contents: One SpermSelect System and one TheCurve
Coopersurgical, Inc.
SM603-F
In Commercial Distribution

  • 60888937003644 ()


  • Spermatozoa/semen motility medium supplement
Contents: one SpermSelect System and one MiniSpace
Coopersurgical, Inc.
SM601-F
In Commercial Distribution

  • 60888937003620 ()


  • Spermatozoa/semen motility medium supplement
CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
AUTOGENOMICS, INC
03-3140-01
Not in Commercial Distribution

  • 00850009370181 ()
03-3140-01

  • Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)
CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
AUTOGENOMICS, INC
03-2140-01
Not in Commercial Distribution

  • 00850009370174 ()
03-2140-01

  • Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)
CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
AUTOGENOMICS, INC
03-1140-01
Not in Commercial Distribution

  • 00850009370167 ()
03-1140-01

  • Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)
No Description
M & T SRL
MT ONE DIAMOND
In Commercial Distribution

  • 08057622080042 ()


  • Dermatological diode laser system
  • Dermatological solid-state laser system
No Description
M & T SRL
MT ONE/D
In Commercial Distribution

  • 08057622080035 ()


  • Dermatological diode laser system
  • Dermatological solid-state laser system
  • Cosmetic red-light phototherapy system, professional
No Description
M & T SRL
Mtone evo lite
In Commercial Distribution

  • 08057622080011 ()


  • Dermatological diode laser system
  • Dermatological solid-state laser system
  • Cosmetic red-light phototherapy system, professional
No Description
M & T SRL
Mtone evo
In Commercial Distribution

  • 08057622080004 ()


  • Dermatological diode laser system
  • Dermatological solid-state laser system
  • Cosmetic red-light phototherapy system, professional
Contents: One SpermSelect System and one Select IUI
Coopersurgical, Inc.
SM602-F
In Commercial Distribution

  • 60888937003637 ()


  • Spermatozoa/semen motility medium supplement
ALFA Sample-2 medium, one small and one large
PREMIER DENTAL PRODUCTS COMPANY
9046085
In Commercial Distribution

  • D6919046085 ()


  • Dental impression tray, single-use
Henry Schein® Root Canal Liquid, 3.5mL Bottle
DENTSPLY INTERNATIONAL INC.
1711435FG
Not in Commercial Distribution

  • D6871711435FG2 ()
  • D6871711435FG0 ()

  • One 1/ 8 oz (3.5mL) Bottle
  • Total Volume: 3.5 Milliliter
1711435FG

  • Hygroscopic dental cement
Self Cure Activator Refill
DENTSPLY INTERNATIONAL INC.
634354
In Commercial Distribution

  • D0026343540 ()

  • Total Volume: 4.5 Milliliter
  • One 4.5mL bottle Self Cure Activator
634354

  • Dentine adhesive
Impactor, One Piece Assembly, Consensus Stem
Shalby Advanced Technologies, Inc.
1800-0-0840
In Commercial Distribution

  • 00840286841962 ()

  • Impactor, One Piece Assembly, Consensus Stem
1800-0-0840

  • Orthopaedic implant impactor, reusable
Resin Cement Syringeable Dual Cure A2 Shade
ESSENTIAL DENTAL SYSTEMS, INC.
980-00
Not in Commercial Distribution

  • 00766054000334 ()

  • One - 9.0 gram dual barrel syringe
980-00

  • Dental composite resin
Resin Cement Syringeable Dual Cure White Opaque Shade
ESSENTIAL DENTAL SYSTEMS, INC.
970-00
Not in Commercial Distribution

  • 00766054000327 ()

  • One - 9.0 gram dual barrel syringe
970-00

  • Dental composite resin
Resin Cement Syringeable Dual Cure Translucent Shade
ESSENTIAL DENTAL SYSTEMS, INC.
960-00
Not in Commercial Distribution

  • 00766054000310 ()

  • One - 9.0 gram dual barrel syringe
960-00

  • Dental composite resin
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