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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Diagnostic ultrasound system
FUJIFILM SONOSITE, INC.
P17000-15
In Commercial Distribution

  • 00841517100032 ()


  • General-purpose ultrasound imaging system
  • Breast ultrasound imaging system
  • Obstetrical/gynaecological ultrasound imaging system
  • Cardiovascular ultrasound imaging system
Diagnostic ultrasound system- transducer
FUJIFILM SONOSITE, INC.
P29671-21
In Commercial Distribution

  • 00841517100018 ()
P29671

  • Extracorporeal ultrasound imaging transducer, hand-held
The Plasmat® Futura System
B.Braun Avitum AG
706210A
Not in Commercial Distribution

  • 04046964337017 ()
706210A

  • Apheresis system
No Description
REMEDI CO.,LTD.
ES70
In Commercial Distribution

  • 08800060100243 ()


  • Portable basic diagnostic x-ray system, digital
No Description
REMEDI CO.,LTD.
ES70
In Commercial Distribution

  • 08800060100236 ()


  • Portable basic diagnostic x-ray system, digital
No Description
REMEDI CO.,LTD.
REMEX KA6
In Commercial Distribution

  • 08800060100151 ()


  • Portable basic diagnostic x-ray system, digital
No Description
REMEDI CO.,LTD.
REMEX T100
In Commercial Distribution

  • 08800060100144 ()


  • Hand-held intraoral dental x-ray system, digital
No Description
REMEDI CO.,LTD.
IoDS-2402
In Commercial Distribution

  • 08800060100069 ()


  • Dental digital imaging sensor, intraoral
No Description
REMEDI CO.,LTD.
IoDS-2401
In Commercial Distribution

  • 08800060100052 ()


  • Dental digital imaging sensor, intraoral
No Description
REMEDI CO.,LTD.
T-100
In Commercial Distribution

  • 08800060100007 ()


  • Hand-held intraoral dental x-ray system, digital
No Description
Olive Healthcare Inc.
AD715-BTWT
Not in Commercial Distribution

  • 08800057400011 ()
  • 18800057400018 ()


  • Bioelectrical body composition analyser
A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to lower extremity motion. It also measures strength and dynamic workload through its computer interface.
BTE TECHNOLOGIES, INC.
LE1
In Commercial Distribution

  • 10850390007816 ()


  • Bicycle ergometer
A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. Neck musculoskeletal measurements can be taken for flexion, extension, lateral flexion, rotation, and for combined planes.
BTE TECHNOLOGIES, INC.
MCU 2
In Commercial Distribution

  • 10850390007427 ()


  • Neck mechanical weight exerciser
A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
Prism1
In Commercial Distribution

  • 10850390007380 ()


  • Biomechanical function analysis system, force-testing, stationary
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
A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
1
In Commercial Distribution

  • 10850390007359 ()


  • Biomechanical function analysis system, force-testing, stationary
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
A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
EvalTech
In Commercial Distribution

  • 10850390007328 ()


  • Biomechanical function analysis system, force-testing, stationary
A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
PrimusRS
In Commercial Distribution

  • 10850390007243 ()


  • Biomechanical function analysis system, force-testing, stationary
A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Primus+
Not in Commercial Distribution

  • 10850390007236 ()


  • Biomechanical function analysis system, force-testing, stationary
SENSOR,O2 PULSE,NLCR,PEDIATRC,DISP,18"
MEDLINE INDUSTRIES, INC.
MDSP2PED-N
In Commercial Distribution

  • 30197344042733 ()
  • 10197344042739 ()
  • 20197344042736 ()
MDSP2PED-N

  • Pulse oximeter probe, single-use
SENSOR,O2 PULSE,NLCR,NEO-ADLT,DISP,18
MEDLINE INDUSTRIES, INC.
MDSP2NAD-N
In Commercial Distribution

  • 30197344042719 ()
  • 10197344042715 ()
  • 20197344042712 ()
MDSP2NAD-N

  • Pulse oximeter probe, single-use
SENSOR,O2 PULSE,NLCR,NEO-ADLT,DISP,36
MEDLINE INDUSTRIES, INC.
MDSP2NAD3-N
In Commercial Distribution

  • 30197344042696 ()
  • 10197344042692 ()
  • 20197344042699 ()
MDSP2NAD3-N

  • Pulse oximeter probe, single-use
SENSOR,O2 PULSE,NLCR,INFANT,DISP,18"
MEDLINE INDUSTRIES, INC.
MDSP2INF-N
In Commercial Distribution

  • 20197344042675 ()
  • 30197344042672 ()
  • 10197344042678 ()
MDSP2INF-N

  • Pulse oximeter probe, single-use
SENSOR,O2 PULSE,NLCR,ADULT,DISP,18"
MEDLINE INDUSTRIES, INC.
MDSP2ADT-N
In Commercial Distribution

  • 20197344042644 ()
  • 30197344042641 ()
  • 10197344042647 ()
MDSP2ADT-N

  • Pulse oximeter probe, single-use
BLADE,CLIPPER,UNIVERSAL,GRAY
MEDLINE INDUSTRIES, INC.
DYND70880
In Commercial Distribution

  • 10884389716083 ()
  • 40884389716084 ()
DYND70880

  • Surgical hair clippers
+ OR Towel, Green, RFID, X-Ray, 2/Pack
STRYKER CORPORATION
0623260020
In Commercial Distribution

  • 07613327513097 ()
  • 57613327513092 ()
0623-260-020

  • Radiopaque woven surgical sponge
+ OR Towel, White, RFID, X-Ray, 2/Pack
STRYKER CORPORATION
0623360020
In Commercial Distribution

  • 07613327513080 ()
  • 57613327513085 ()
0623-360-020

  • Radiopaque woven surgical sponge
+ OR Towel, Blue, RFID, X-Ray, 2/Pack
STRYKER CORPORATION
0623160020
In Commercial Distribution

  • 07613327513073 ()
  • 57613327513078 ()
0623-160-020

  • Radiopaque woven surgical sponge
+ SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, No Loop
STRYKER CORPORATION
0621218180
In Commercial Distribution

  • 07613327512762 ()
  • 57613327512767 ()
0621-218-180

  • Radiopaque woven surgical sponge
+ SAFE-T-Lap Sponge, 18 inch x 36 inch, RFID, X-Ray
STRYKER CORPORATION
0621318360
In Commercial Distribution

  • 07613327512755 ()
  • 57613327512750 ()
0621-318-360

  • Radiopaque woven surgical sponge
+ SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, Plastic Ring
STRYKER CORPORATION
0621118180
In Commercial Distribution

  • 07613327512748 ()
  • 57613327512743 ()
0621-118-180

  • Radiopaque woven surgical sponge
+ SAFE-T-Lap Sponge, 12 inch x 12 inch, RFID, X-Ray
STRYKER CORPORATION
0621012120
In Commercial Distribution

  • 07613327512731 ()
  • 57613327512736 ()
0621-012-120

  • Radiopaque woven surgical sponge
+ SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray, Plastic Ring
STRYKER CORPORATION
0621108360
In Commercial Distribution

  • 07613327512724 ()
  • 57613327512729 ()
0621-108-360

  • Radiopaque woven surgical sponge
+ SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray
STRYKER CORPORATION
0621018180
In Commercial Distribution

  • 07613327512717 ()
  • 57613327512712 ()
0621-018-180

  • Radiopaque woven surgical sponge
+ SAFE-T-Lap Sponge, 4 inch x 18 inch, RFID, X-Ray
STRYKER CORPORATION
0621004180
In Commercial Distribution

  • 07613327512700 ()
  • 57613327512705 ()
0621-004-180

  • Radiopaque woven surgical sponge
+ Gauze Sponge, 4 inch x 4 inch, 16 Ply, RFID, Double Wavy X-Ray
STRYKER CORPORATION
0622344160
In Commercial Distribution

  • 07613327512571 ()
  • 57613327512576 ()
0622-344-160

  • Radiopaque woven surgical sponge
+ Gauze Sponge, 8 inch x 4 inch, 24 Ply, RFID, Double X-Ray
STRYKER CORPORATION
0622284240
In Commercial Distribution

  • 37613327512565 ()
  • 57613327512569 ()
  • 07613327512564 ()
0622-284-240

  • Radiopaque woven surgical sponge
+ Gauze Sponge, 8 inch x 4 inch, 16 Ply, RFID, Double X-Ray
STRYKER CORPORATION
0622284160
In Commercial Distribution

  • 07613327512557 ()
  • 57613327512552 ()
0622-284-160

  • Radiopaque woven surgical sponge
+ Gauze Sponge, 4 inch x 4 inch, 32 Ply, RFID, Double X-Ray
STRYKER CORPORATION
0622244320
In Commercial Distribution

  • 07613327512540 ()
  • 57613327512545 ()
0622-244-320

  • Radiopaque woven surgical sponge
+ Gauze Sponge, 8 inch x 4 inch, 12 Ply, RFID, Double X-Ray
STRYKER CORPORATION
0622284120
In Commercial Distribution

  • 07613327512533 ()
  • 57613327512538 ()
0622-284-120

  • Radiopaque woven surgical sponge
+ Gauze Sponge, 4 inch x 4 inch, 16 Ply, RFID, Double X-Ray
STRYKER CORPORATION
0622244160
In Commercial Distribution

  • 07613327512526 ()
  • 57613327512521 ()
0622-244-160

  • Radiopaque woven surgical sponge
+ Gauze Sponge, 2 inch x 2 inch, 12 Ply, RFID, X-Ray
STRYKER CORPORATION
0622022120
In Commercial Distribution

  • 07613327512519 ()
  • 57613327512514 ()
0622-022-120

  • Radiopaque woven surgical sponge
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
GAMBRO AB
7.21
Not in Commercial Distribution

  • 07332414126766 ()
955792

  • Haemodialysis system, institutional
+ SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray
STRYKER CORPORATION
0621008360
In Commercial Distribution

  • 07613327513189 ()
  • 57613327513184 ()
0621-008-360

  • Radiopaque woven surgical sponge
+ OR Towel, White, RFID, X-Ray, 5/Pack
STRYKER CORPORATION
0623360050
In Commercial Distribution

  • 07613327513141 ()
  • 57613327513146 ()
0623-360-050

  • Radiopaque woven surgical sponge
+ OR Towel, Green, RFID, X-Ray, 5/Pack
STRYKER CORPORATION
0623260050
In Commercial Distribution

  • 07613327513134 ()
  • 57613327513139 ()
0623-260-050

  • Radiopaque woven surgical sponge
+ OR Towel, Blue, RFID, X-Ray, 5/Pack
STRYKER CORPORATION
0623160050
In Commercial Distribution

  • 07613327513127 ()
  • 57613327513122 ()
0623-160-050

  • Radiopaque woven surgical sponge
TD I-110 (2nd Generation) Portable Speech Generating Device designed for people who can not speak due to injury, illness or disability. Durable, lightweight unit, IP55 with Gorilla Glass.
TOBII DYNAVOX LLC
TD I-110
In Commercial Distribution

  • 07340074602094 ()
1000800

  • Voice synthesizer/digitizer
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