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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NextAR tap aggressive undersize Ø6 depth 100mm
Medacta International SA
03.57.10.0198
In Commercial Distribution

  • 07630542714566 ()


  • Optical surgical navigation device tracking system
NextAR Spine Solid Drill Ø3.6mm depth 100mm
Medacta International SA
03.57.10.0197
In Commercial Distribution

  • 07630542714559 ()


  • Optical surgical navigation device tracking system
NextAR Spine Solid Drill Ø3.6mm depth 80mm
Medacta International SA
03.57.10.0196
In Commercial Distribution

  • 07630542714542 ()


  • Optical surgical navigation device tracking system
NextAR Spine Solid Drill Ø3.6mm depth 60mm
Medacta International SA
03.57.10.0195
In Commercial Distribution

  • 07630542714535 ()


  • Optical surgical navigation device tracking system
NextAR Spine Solid Drill Ø3.2mm depth 100mm
Medacta International SA
03.57.10.0194
In Commercial Distribution

  • 07630542714528 ()


  • Optical surgical navigation device tracking system
NextAR Spine Solid Drill Ø3.2mm depth 80mm
Medacta International SA
03.57.10.0193
In Commercial Distribution

  • 07630542714511 ()


  • Optical surgical navigation device tracking system
NextAR Spine Solid Drill Ø3.2mm depth 60mm
Medacta International SA
03.57.10.0192
In Commercial Distribution

  • 07630542714504 ()


  • Optical surgical navigation device tracking system
NextAR Spine Solid Drill Ø2.7mm depth 100mm
Medacta International SA
03.57.10.0191
In Commercial Distribution

  • 07630542714498 ()


  • Optical surgical navigation device tracking system
NextAR Spine Solid Drill Ø2.7mm depth 80mm
Medacta International SA
03.57.10.0190
In Commercial Distribution

  • 07630542714481 ()


  • Optical surgical navigation device tracking system
NextAR Spine Solid Drill Ø2.7mm depth 60mm
Medacta International SA
03.57.10.0189
In Commercial Distribution

  • 07630542714474 ()


  • Optical surgical navigation device tracking system
NextAR Spine Tray MC Instruments
Medacta International SA
03.57.10.0310
In Commercial Distribution

  • 07630542707186 ()


  • Optical surgical navigation device tracking system
The ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities. The ReJoyce helps patients to retrain and condition their muscles by using their hands and arms to play interactive computer games. The activities required by the computer games are similar to tasks used in everyday life, such as pouring a drink or opening a jar. Practicing these motions will help patients to replicate them in real life.
Rehabtronics Inc
RV10
In Commercial Distribution

  • 17540176010002 ()


  • Virtual-display arm rehabilitation system, non-gravity-compensating
PMD-200 monitor with NOL Nociception Level Technology
MEDASENSE BIOMETRICS LTD
PMD200-2
In Commercial Distribution

  • 07290017287232 ()
  • 07290017287348 ()
SYS-1FP-23

  • Analgesia nociception index monitoring system
No Description
MEDASENSE BIOMETRICS LTD
FP200-2
In Commercial Distribution

  • 07290017287249 ()
  • 07290017287294 ()
PMD-FNP-21

  • Analgesia nociception index monitoring system
No Description
MEDASENSE BIOMETRICS LTD
MEK-0002
In Commercial Distribution

  • 07290017287027 ()
  • 07290017287201 ()
  • 07290017287034 ()
MEK-0002

  • Analgesia nociception index monitoring system
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2700-I
In Commercial Distribution

  • 10840113231307 ()
  • 00840113231300 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2750OEMDSP
In Commercial Distribution

  • 20840113230444 ()
  • 10840113230447 ()
  • 00840113230440 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin, also provides a permanent method of identifying objects in the operating room
ASPEN SURGICAL PRODUCTS, INC.
2701
In Commercial Distribution

  • 00840113230297 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2700BN
In Commercial Distribution

  • 00840113230280 ()
  • 00840113230273 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin, also provides a permanent method of identifying objects in the operating room
ASPEN SURGICAL PRODUCTS, INC.
2700
In Commercial Distribution

  • 00840113230266 ()
  • 00840113230259 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin, also provides a permanent method of identifying objects in the operating room
ASPEN SURGICAL PRODUCTS, INC.
2715
In Commercial Distribution

  • 00840113230242 ()
  • 00840113230235 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
100L-00-PDG
In Commercial Distribution

  • 00840113225187 ()
  • 00840113225170 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
1002-00-PDG
In Commercial Distribution

  • 00840113225149 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
1000-00-PDG
In Commercial Distribution

  • 00840113225156 ()
  • 00840113225132 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
1400-16-PDC
In Commercial Distribution

  • 00840113225118 ()
  • 00840113225101 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
10L3-00-PDG
In Commercial Distribution

  • 00840113225095 ()
  • 00840113225088 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
1003-00-PDG
In Commercial Distribution

  • 00840113225071 ()
  • 00840113225064 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
1400-15-PDC
In Commercial Distribution

  • 00840113225057 ()
  • 00840113225040 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
1400-13-PDC
In Commercial Distribution

  • 00840113225033 ()
  • 00840113225026 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
1400-20-PDC
In Commercial Distribution

  • 00840113225002 ()


  • Skin marking pen, single-use
Intended used to provide a permanent method of identifying objects in the operating room
ASPEN SURGICAL PRODUCTS, INC.
ML5832
In Commercial Distribution

  • 00840113223060 ()
  • 00840113223053 ()
  • 00840113223046 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2651
In Commercial Distribution

  • 00840113222674 ()
  • 00840113222667 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2650
In Commercial Distribution

  • 00840113222636 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2551
In Commercial Distribution

  • 00840113222612 ()
  • 00840113222605 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2550BN
In Commercial Distribution

  • 00840113222599 ()
  • 00840113222582 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2550BN-R
In Commercial Distribution

  • 00840113222575 ()
  • 00840113222568 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2752BN
In Commercial Distribution

  • 00840113222551 ()
  • 00840113222544 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2751
In Commercial Distribution

  • 00840113222537 ()
  • 00840113222520 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2730BN
In Commercial Distribution

  • 00840113222506 ()
  • 00840113222490 ()


  • Skin marking pen, single-use
Intended use for surgical marking on intact skin
ASPEN SURGICAL PRODUCTS, INC.
2531
In Commercial Distribution

  • 00840113222469 ()
  • 00840113222452 ()


  • Skin marking pen, single-use
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