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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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E-Sphyg™ II - 00634782057909

Mounting Plate-9002,w/hardware
AMERICAN DIAGNOSTIC CORP
9002-6
In Commercial Distribution

  • 00634782057909 ()
9002-6

  • Blood pressure cuff, reusable

SPATIAL FRAME - 00885556012963

SPATIAL FRAME HARDWARE CASE
Smith & Nephew, Inc.
71070380
In Commercial Distribution

  • 00885556012963 ()
71070380

  • Instrument tray, reusable

SMART TSF - 00885556746264

SMART TSF HARDWARE CASE
Smith & Nephew, Inc.
71075502
In Commercial Distribution

  • 00885556746264 ()
71075502

  • Instrument tray, reusable

N/A - 00885074366722

HARDWARE 9731838 POLESTAR INTEGRATION
MEDTRONIC NAVIGATION, INC.
9731838
In Commercial Distribution

  • 00885074366722 ()


  • Extremity MRI system, permanent magnet

InMode - 07290016633252

InMode system - new hardware
INMODE M.D LTD
AG606666A
In Commercial Distribution

  • 07290016633252 ()
AG606666A

  • Multi-modality skin surface treatment system

MJS System 3 Upgrade - 00718175004050

BIODEX SYSTEM 3 REMANUFACTURE
BIODEX MEDICAL SYSTEMS, INC.
850-820
Not in Commercial Distribution

  • 00718175004050 ()
850-820

  • Biomechanical function analysis/interactive rehabilitation system

mTrigger - 00863712000337

mTrigger Biofeedback System
MTRIGGER, LLC
BI2612/BK2613
In Commercial Distribution

  • 00863712000337 ()


  • Biomechanical function analysis/interactive rehabilitation system

KForce Deltas XL - 03770011995608

K Deltas are two large independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength
KINVENT BIOMECANIQUE
K Deltas XL V3
In Commercial Distribution

  • 03770011995608 ()


  • Biomechanical function analysis system, force-testing, portable

KForce Deltas - 03770011995417

K Deltas are two large independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength
KINVENT BIOMECANIQUE
K Deltas V3
In Commercial Distribution

  • 03770011995417 ()


  • Biomechanical function analysis system, force-testing, portable

KForce Plates - 03770011995387

K Plates are two independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength
KINVENT BIOMECANIQUE
K Force Plates V3
In Commercial Distribution

  • 03770011995387 ()


  • Biomechanical function analysis system, force-testing, portable

KINVENT - 03770011995226

Plates are two independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength.
KINVENT HELLAS
Plates V2R01
In Commercial Distribution

  • 03770011995226 ()


  • Biomechanical function analysis system, force-testing, portable

KINVENT - 03770011995097

Deltas are two independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength.
KINVENT HELLAS
Deltas V2R01
In Commercial Distribution

  • 03770011995097 ()


  • Biomechanical function analysis system, force-testing, portable

EVJ - 10850390007366

A portable measurement system for quantifying musculoskeletal strength and range of motion.
BTE TECHNOLOGIES, INC.
Evaluator EVJ
In Commercial Distribution

  • 10850390007366 ()


  • Biomechanical function analysis system, force-testing, portable

Evaluator EV2 - 10850390007342

No Description
BTE TECHNOLOGIES, INC.
EV2
Not in Commercial Distribution

  • 10850390007342 ()


  • Biomechanical function analysis system, force-testing, portable

Evaluator - 10850390007373

A portable measurement system for quantifying musculoskeletal strength and range of motion. Various EV versions are available that are different configurations of the same medical device model.
BTE TECHNOLOGIES, INC.
Evaluator EV
Not in Commercial Distribution

  • 10850390007373 ()


  • Biomechanical function analysis system, force-testing, portable

Evaluator - 10850390007335

A portable measurement system for quantifying musculoskeletal strength and range of motion.
BTE TECHNOLOGIES, INC.
Evaluator
In Commercial Distribution

  • 10850390007335 ()


  • Biomechanical function analysis system, force-testing, portable

OmnisEMG - B179OMNI13E87E4

Biomechanical function analysis / interactive rehabilitation system
ACCELERATED CARE PLUS CORP
44144
In Commercial Distribution

  • B179OMNI13E87E4 ()


  • Biomechanical function analysis/interactive rehabilitation system

Stainless Steel Facial Ice Globe - 00860009308008

This ice globe is made of 304 stainless steel and filled with refrigerant. Put it in the refrigerator for 3-4 hours before use, roll it slowly on the face, and enjoy the cool and calm massage effect. It is applicable to the face, neck and other parts.
Jiangmen Shengke Hardware Products Co., Ltd
Set
In Commercial Distribution

  • 00860009308008 ()


  • External manual massager, home-use

Stainless Steel Facial Ice Globe - 00860009308015

This ice globe is made of 304 stainless steel and filled with refrigerant. Put it in the refrigerator for 3-4 hours before use, roll it slowly on the face, and enjoy the cool and calm massage effect. It is applicable to the face, neck and other parts.
Jiangmen Shengke Hardware Products Co., Ltd
Duo Set
In Commercial Distribution

  • 00860009308015 ()


  • External manual massager, home-use

FUKUDA DENSHI - 04538612916014

No Description
FUKUDA DENSHI CO.,LTD.
FP-908LP
In Commercial Distribution

  • 04538612916014 ()


  • Software upgrade/unlocking key

FUKUDA DENSHI - 04538612916007

No Description
FUKUDA DENSHI CO.,LTD.
FP-908A
In Commercial Distribution

  • 04538612916007 ()


  • Software upgrade/unlocking key

FUKUDA DENSHI - 04538612915154

No Description
FUKUDA DENSHI CO.,LTD.
FP-811
In Commercial Distribution

  • 04538612915154 ()


  • Software upgrade/unlocking key

Pure Vue - 10886705032204

Pure Vue Software expansion
Medos International Sàrl
242329
In Commercial Distribution

  • 10886705032204 ()
242329

  • Software upgrade/unlocking key

BLUE LIGHT IMAGING UNIT - 04953170396021

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2305
In Commercial Distribution

  • 04953170396021 ()
N5769640

  • Software upgrade/unlocking key

Infrared imaging unit - 04953170395994

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2304
In Commercial Distribution

  • 04953170395994 ()


  • Software upgrade/unlocking key

AUTO FOCUS UNIT - 04953170395963

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2303
In Commercial Distribution

  • 04953170395963 ()


  • Software upgrade/unlocking key

OTV-S500 UPGRADE PACK STROBE - 04953170458170

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2547
In Commercial Distribution

  • 04953170458170 ()
N6216940

  • Software upgrade/unlocking key

OTV-S700 UPGRADE PACK 3D - 04953170445453

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2511
In Commercial Distribution

  • 04953170445453 ()
N6189440

  • Software upgrade/unlocking key

SWQ SOFTWARE OPTION - 04953170431906

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2383
In Commercial Distribution

  • 04953170431906 ()
N6157530

  • Software upgrade/unlocking key

ELST SOFTWARE OPTION - 04953170431890

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2382
In Commercial Distribution

  • 04953170431890 ()
N6157430

  • Software upgrade/unlocking key

CHE SOFTWARE OPTION - 04953170431883

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2381
In Commercial Distribution

  • 04953170431883 ()
N6157330

  • Software upgrade/unlocking key

Infrared imaging unit - 04953170424724

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2304
Not in Commercial Distribution

  • 04953170424724 ()


  • Software upgrade/unlocking key

UPGRADE KIT FOR UCES-3 (Version 4) - 04953170335464

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2051
Not in Commercial Distribution

  • 04953170335464 ()


  • Software upgrade/unlocking key

CHATTANOOGA - 00888912296533

CARD MULTIMEDIA DTS
DJO, LLC
2842
In Commercial Distribution

  • 00888912296533 ()


  • Software upgrade/unlocking key

Internal Battery PM Upgrade USB Drive - 00850018761413

Eaches- Internal Battery PM Upgrade USB Drive, PRT-01846-000 - 00850018761413 Packaged, Internal Battery PM Upgrade USB Drive (5-Pack), PRT-01848-000 - 00850018761420
VENTEC LIFE SYSTEMS, INC.
PRT-01846-000
In Commercial Distribution

  • 00850018761413 ()
  • 00850018761420 ()
PRT-01846-000

  • Software upgrade/unlocking key

Lazurite Holdings LLC ArthroFree Sterilization Tray Kit - 00850045863005

No Description
Lazurite Holdings LLC
AF0030-101-10
In Commercial Distribution

  • 00850045863005 ()


  • Video camera surgical microscope system

Lazurite Holdings LLC ArthroFree Sterilization Tray Kit - 00860001744293

No Description
Lazurite Holdings LLC
AF0030-101-10
In Commercial Distribution

  • 00860001744293 ()


  • Video camera surgical microscope system

Lazurite Holdings LLC ArthroFree Battery Charger Kit - 00860001744286

No Description
Lazurite Holdings LLC
AF0029-101-10
In Commercial Distribution

  • 00860001744286 ()


  • Video camera surgical microscope system

Lazurite Holdings LLC ArthroFree Receiver Kit - 00860001744279

No Description
Lazurite Holdings LLC
AF0028-101-10
In Commercial Distribution

  • 00860001744279 ()


  • Video camera surgical microscope system

Lazurite Holdings LLC ArthroFree Additional Camera Kit - 00860001744262

No Description
Lazurite Holdings LLC
AF0014-101-10
In Commercial Distribution

  • 00860001744262 ()


  • Video camera surgical microscope system

Lazurite Holdings LLC ArthroFree Operating Room Kit - 00860001744255

No Description
Lazurite Holdings LLC
AF0013-101-11
In Commercial Distribution

  • 00860001744255 ()


  • Video camera surgical microscope system

Lazurite Holdings LLC Receiver - 00860001744248

No Description
Lazurite Holdings LLC
AF0002-101-10
In Commercial Distribution

  • 00860001744248 ()


  • Video camera surgical microscope system

Lazurite Holdings LLC Battery Charger - 00860001744231

No Description
Lazurite Holdings LLC
AF0004-101-10
In Commercial Distribution

  • 00860001744231 ()


  • Video camera surgical microscope system

Lazurite Holdings LLC Battery - 00860001744224

No Description
Lazurite Holdings LLC
AF0003-101-10
In Commercial Distribution

  • 00860001744224 ()


  • Video camera surgical microscope system

Lazurite Holdings LLC Sterilization Tray - 00860001744217

No Description
Lazurite Holdings LLC
AF0005-101-10
In Commercial Distribution

  • 00860001744217 ()


  • Video camera surgical microscope system

Lazurite Holdings LLC Wireless Camera Head - 00860001744200

No Description
Lazurite Holdings LLC
AF0001-101-10
In Commercial Distribution

  • 00860001744200 ()


  • Video camera surgical microscope system

NA - 04048551432518

Micromanipulator Interface VITOM 3D
Karl Storz GmbH & Co. KG
TH004
In Commercial Distribution

  • 04048551432518 ()
TH004

  • Video camera surgical microscope system

NA - 04048551418871

VITOM EAGLE
Karl Storz GmbH & Co. KG
TH201
In Commercial Distribution

  • 04048551418871 ()
TH201

  • Video camera surgical microscope system

VITOM - 04048551387245

VITOM® 3D
Karl Storz GmbH & Co. KG
TH200
In Commercial Distribution

  • 04048551387245 ()


  • Video camera surgical microscope system

Lazurite Holdings LLC ArthroFree Battery Set - 10860001744221

No Description
Lazurite Holdings LLC
AF0015-101-10
In Commercial Distribution

  • 10860001744221 ()


  • Video camera surgical microscope system
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