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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Berchtold Surgical Table, D 760
Berchtold Holding GmbH
OT 7606575
In Commercial Distribution

  • 07613327170030 ()
OT 7606575

  • Universal operating table, electrohydraulic
Berchtold Surgical Table, D 830
Berchtold Holding GmbH
OT 8301175
In Commercial Distribution

  • 07613327170023 ()
OT 8301175

  • Universal operating table, electrohydraulic
Berchtold Surgical Table, D830
Berchtold Holding GmbH
OT 8301165
In Commercial Distribution

  • 07613327170016 ()
OT 8301165

  • Universal operating table, electrohydraulic
Berchtold Surgical Table, D 820
Berchtold Holding GmbH
OT 8204575
In Commercial Distribution

  • 07613327170009 ()
OT 8204575

  • Universal operating table, electrohydraulic
Berchtold Surgical Table, D 830
Berchtold Holding GmbH
OT 8301065
In Commercial Distribution

  • 07613327169997 ()
OT 8301065

  • Universal operating table, electrohydraulic
Berchtold Surgical Table, D 770
Berchtold Holding GmbH
OT 7701066
In Commercial Distribution

  • 07613327169973 ()
OT 7701066

  • Universal operating table, electrohydraulic
Berchtold Surgical Table, D 750
Berchtold Holding GmbH
OT 1801075
Not in Commercial Distribution

  • 07613327169959 ()
OT 1801075

  • Universal operating table, electrohydraulic
Berchtold Surgical Table D 850
Berchtold Holding GmbH
OT 1702175
Not in Commercial Distribution

  • 07613327169935 ()
OT 1702175

  • Universal operating table, electrohydraulic
Berchtold Surgical Table, D 770
Berchtold Holding GmbH
OT 7701065
In Commercial Distribution

  • 07613327169928 ()
OT 7701065

  • Universal operating table, electrohydraulic
Berchtold Surgical Table, D 750
Berchtold Holding GmbH
OT 1802075
Not in Commercial Distribution

  • 07613327169911 ()
OT 1802075

  • Universal operating table, electrohydraulic
Berchtold Surgical Table, D 850
Berchtold Holding GmbH
OT 1701175
Not in Commercial Distribution

  • 07613327169904 ()
OT 1701175

  • Universal operating table, electrohydraulic
Berchtold Surgical Table, D 850
Berchtold Holding GmbH
OT 1701075
Not in Commercial Distribution

  • 07613327169898 ()
OT 1701075

  • Universal operating table, electrohydraulic
Berchtold Surgical Table, D 850
Berchtold Holding GmbH
OT 1702075
Not in Commercial Distribution

  • 07613327169874 ()
OT 1702075

  • Universal operating table, electrohydraulic
No Description
STRYKER CORPORATION
FL28EX
Not in Commercial Distribution

  • 07613327169386 ()
FL28EX

  • Basic electric hospital bed
No Description
STRYKER CORPORATION
FL19H
In Commercial Distribution

  • 07613327169348 ()
FL19H

  • Neonatal bed
No Description
STRYKER CORPORATION
2131
In Commercial Distribution

  • 07613327169294 ()
2131-000-000

  • Basic electric hospital bed
No Description
STRYKER CORPORATION
2141
In Commercial Distribution

  • 07613327169232 ()
2141-000-000

  • Basic electric hospital bed
CranialMask Tracker
Stryker Leibinger GmbH & Co. KG
6000-390-000
In Commercial Distribution

  • 37613327097628 ()
  • 07613327097627 ()
6000-390-000

  • Optical surgical navigation device tracking system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1 Software
In Commercial Distribution

  • 00812059021482 ()
100074942

  • Coronary optical coherence tomography system
Tableside Controller
LIGHTLAB IMAGING, INC.
C408663
In Commercial Distribution

  • 00812059021444 ()
C408663

  • Coronary optical coherence tomography system
Upgrade Kit
LIGHTLAB IMAGING, INC.
Mobile System
In Commercial Distribution

  • 00812059021437 ()
C408662

  • Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
Integrated System E.2 Software
In Commercial Distribution

  • 00812059021390 ()
C408657

  • Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
OPTIS™ E.2 Software
In Commercial Distribution

  • 00812059021383 ()
C408656

  • Coronary optical coherence tomography system
Mobile Workstation
LIGHTLAB IMAGING, INC.
C408653
In Commercial Distribution

  • 00812059020126 ()
C408653

  • Coronary optical coherence tomography system
Installation Kit
LIGHTLAB IMAGING, INC.
Integrated System
In Commercial Distribution

  • 00812059020003 ()
C408654

  • Coronary optical coherence tomography system
Apex Locator
J.MORITA MFG.CORP.
RCM-7
In Commercial Distribution

  • 00887919758013 ()
5025412U0

  • Endodontic apex locator
Cordless Endo Motor
J.MORITA MFG.CORP.
TR-CM
In Commercial Distribution

  • 00887919832249 ()
5027135U0

  • Dental surgical power tool motorized handpiece/set, electric
WATER BATH CONSOLE, 230V
Stryker Leibinger GmbH & Co. KG
70-76005
In Commercial Distribution

  • 07613153066989 ()
70-76005

  • Surgical water bath system
ZEISS NC4 MICROSCOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-055-000
In Commercial Distribution

  • 07613252516941 ()
7700-055-000

  • Multi-purpose stereotactic surgery system
LEICA MICROSCOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-065-000
In Commercial Distribution

  • 07613252516934 ()
7700-065-000

  • Multi-purpose stereotactic surgery system
ZEISS PENTERO MICROSKOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-075-000
In Commercial Distribution

  • 07613252516927 ()
7700-075-000

  • Multi-purpose stereotactic surgery system
Radiation Therapy QA Device. For use with the 1230 3D SCANNER.
SUN NUCLEAR CORP.
12300009Z
In Commercial Distribution

  • B01612300009Z0 ()
12300009Z

  • Accelerator system quality assurance device
Accessory to the 1230 3D SCANNER.
SUN NUCLEAR CORP.
12300004Z
Not in Commercial Distribution

  • B01612300004Z0 ()
12300004Z

  • Accelerator system quality assurance device
Radiation therapy QA device.
SUN NUCLEAR CORP.
12300000Z
Not in Commercial Distribution

  • B01612300000Z0 ()
12300000Z

  • Accelerator system quality assurance device
Radiation therapy QA device.
SUN NUCLEAR CORP.
12300000TZ
In Commercial Distribution

  • B01612300000TZ0 ()
12300000TZ

  • Accelerator system quality assurance device
Radiation therapy QA device.
SUN NUCLEAR CORP.
10460000Z
In Commercial Distribution

  • B01610460000Z0 ()
10460000Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
10450001Z
In Commercial Distribution

  • B01610450001Z0 ()
10450001Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
10470001Z
In Commercial Distribution

  • B01610470001Z0 ()
10470001Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
10470000Z
Not in Commercial Distribution

  • B01610470000Z0 ()
10470000Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
10460001Z
In Commercial Distribution

  • B01610460001Z0 ()
10460001Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
10450000Z
In Commercial Distribution

  • B01610450000Z0 ()
10450000Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
10410001Z
Not in Commercial Distribution

  • B01610410001Z0 ()
10410001Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
10410000Z
Not in Commercial Distribution

  • B01610410000Z0 ()
10410000Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
10140001Z
Not in Commercial Distribution

  • B01610140001Z0 ()
10140001Z

  • Radiation electrometer
Radiation therapy QA device.
SUN NUCLEAR CORP.
10140000Z
Not in Commercial Distribution

  • B01610140000Z0 ()
10140000Z

  • Radiation electrometer
Installation Kit
LIGHTLAB IMAGING, INC.
Mobile System
In Commercial Distribution

  • 00812059021994 ()
C408667

  • Coronary optical coherence tomography system
Installation Kit
LIGHTLAB IMAGING, INC.
Mobile System
In Commercial Distribution

  • 00812059021987 ()
C408666

  • Coronary optical coherence tomography system
Software Upgrade
LIGHTLAB IMAGING, INC.
Software Upgrade
In Commercial Distribution

  • 00812059021925 ()
E4-STD-WW

  • Coronary optical coherence tomography system
Software Upgrade
LIGHTLAB IMAGING, INC.
Metallic Stent Optimization Software
In Commercial Distribution

  • 00812059021918 ()
E4-FULL-WW

  • Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
C.0.4 Software Upgrade
In Commercial Distribution

  • 00812059021536 ()
15211-01

  • Coronary optical coherence tomography system
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