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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Ex-Fix Hardware Removal, Tray
ORTHOPEDIATRICS CORP.
01-2200-0202
In Commercial Distribution

  • 00840194466103 ()
01-2200-0202

  • Instrument tray, reusable
Ex-Fix Hardware Removal, Case
ORTHOPEDIATRICS CORP.
01-2200-0201
In Commercial Distribution

  • 00840194466097 ()
01-2200-0201

  • Instrument tray, reusable
HEADREST HARDWARE, SURELOCK MULTI-AXIS.
Therafin Corporation
50218
In Commercial Distribution

  • 00840252901096 ()
50218

  • Wheelchair/chair/stander headrest
HEADREST HARDWARE, MULTI-AXIS OFFSET.
Therafin Corporation
50215
In Commercial Distribution

  • 00840252901089 ()
50215

  • Wheelchair/chair/stander headrest
Hardware Removal Caddy, Lid
Paragon 28, Inc.
SP99-LID-0001
In Commercial Distribution

  • 00889795141590 ()
SP99-LID-0001

  • Device sterilization/disinfection container, reusable
Hardware Removal Caddy, Base
Paragon 28, Inc.
SP99-CAD-0001
In Commercial Distribution

  • 00889795141583 ()
SP99-CAD-0001

  • Device sterilization/disinfection container, reusable
GALILEOS Hardware Comfort PLUS
SIRONA Dental Systems GmbH
6448877
Not in Commercial Distribution

  • E27664488770 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
GALILEOS Hardware Comfort PLUS
SIRONA Dental Systems GmbH
6299999
Not in Commercial Distribution

  • E27662999990 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Wire basket with hardware
Touchpoint Medical, Inc.
CD.06085.799
In Commercial Distribution

  • 00840178701466 ()


  • Electromechanical device/system transport trolley
HARDWARE KIT FOR VP8532
Conmed Corporation
VP8567
In Commercial Distribution

  • 10845854041581 ()
VP8567

  • Medical device integration rack
STERILE HARDWARE REMOVAL PACK
Cardinal Health 200, LLC
SOP81HRNEF
In Commercial Distribution

  • 50887488156918 ()
  • 10887488156910 ()
SOP81HRNEF

  • Orthopaedic surgical procedure kit, non-medicated, single-use
InMode system - new hardware
INMODE M.D LTD
AG606666A
In Commercial Distribution

  • 07290016633252 ()
AG606666A

  • Multi-modality skin surface treatment system
HARDWARE 9731838 POLESTAR INTEGRATION
MEDTRONIC NAVIGATION, INC.
9731838
In Commercial Distribution

  • 00885074366722 ()


  • Extremity MRI system, permanent magnet
SMART TSF HARDWARE CASE
Smith & Nephew, Inc.
71075502
In Commercial Distribution

  • 00885556746264 ()
71075502

  • Instrument tray, reusable
SPATIAL FRAME HARDWARE CASE
Smith & Nephew, Inc.
71070380
In Commercial Distribution

  • 00885556012963 ()
71070380

  • Instrument tray, reusable
mTrigger Biofeedback System
MTRIGGER, LLC
BI2612/BK2613
In Commercial Distribution

  • 00863712000337 ()


  • Biomechanical function analysis/interactive rehabilitation system
BIODEX SYSTEM 3 REMANUFACTURE
BIODEX MEDICAL SYSTEMS, INC.
850-820
Not in Commercial Distribution

  • 00718175004050 ()
850-820

  • Biomechanical function analysis/interactive rehabilitation system
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
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
No Description
BTE TECHNOLOGIES, INC.
EV2
Not in Commercial Distribution

  • 10850390007342 ()


  • Biomechanical function analysis system, force-testing, portable
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
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
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
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
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
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
Biomechanical function analysis / interactive rehabilitation system
ACCELERATED CARE PLUS CORP
44144
In Commercial Distribution

  • B179OMNI13E87E4 ()


  • Biomechanical function analysis/interactive rehabilitation system
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
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
Hardware Removal, Plate & Screw, Upper Tray
ORTHOPEDIATRICS CORP.
01-9200-5002
In Commercial Distribution

  • 00840194466905 ()
01-9200-5002

  • Instrument tray, reusable
Hardware Removal, Plate & Screw, Case
ORTHOPEDIATRICS CORP.
01-9200-5001
In Commercial Distribution

  • 00840194466899 ()
01-9200-5001

  • Instrument tray, reusable
Screw Forceps
ORTHOPEDIATRICS CORP.
01-9200-1000
In Commercial Distribution

  • 00840194465304 ()
01-9200-1000

  • Surgical implant handling forceps
Driver, Cannulated 5.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0150
In Commercial Distribution

  • 00840194465298 ()
01-9200-0150

  • Surgical screwdriver, reusable
Driver, Solid 5.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0050
In Commercial Distribution

  • 00840194465281 ()
01-9200-0050

  • Surgical screwdriver, reusable
Driver, Cannulated 4.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0145
In Commercial Distribution

  • 00840194465274 ()
01-9200-0145

  • Surgical screwdriver, reusable
Driver, Solid 4.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0045
In Commercial Distribution

  • 00840194465267 ()
01-9200-0045

  • Surgical screwdriver, reusable
Driver, Cannulated 4.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0140
In Commercial Distribution

  • 00840194465250 ()
01-9200-0140

  • Surgical screwdriver, reusable
Driver, Solid 4.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0040
In Commercial Distribution

  • 00840194465243 ()
01-9200-0040

  • Surgical screwdriver, reusable
Driver, Cannulated 3.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0135
In Commercial Distribution

  • 00840194465236 ()
01-9200-0135

  • Surgical screwdriver, reusable
Driver, Solid 3.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0035
In Commercial Distribution

  • 00840194465229 ()
01-9200-0035

  • Surgical screwdriver, reusable
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