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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Actiwatch Spectrum Pro
Respironics, Inc.
Actiwatch Spectrum Pro
In Commercial Distribution

  • 00606959021402 ()
1099351

  • Kinesiology ambulatory recorder
Actical Software Global
Respironics, Inc.
3.11
In Commercial Distribution

  • 00606959021013 ()
1081738

  • Kinesiology ambulatory recorder
Actical
Respironics, Inc.
ACTICAL
In Commercial Distribution

  • 00606959021006 ()
1081737

  • Kinesiology ambulatory recorder
Actiwatch 2 Communication Dock System
Respironics, Inc.
Actiwatch 2 Communication Dock System
In Commercial Distribution

  • 00606959003903 ()
1048092

  • Kinesiology ambulatory recorder
Actiwatch 2 Device
Respironics, Inc.
Actiwatch 2 Device
In Commercial Distribution

  • 00606959003897 ()
1048090

  • Kinesiology ambulatory recorder
Actiwatch 2 System
Respironics, Inc.
Actiwatch 2 System
In Commercial Distribution

  • 00606959003842 ()
1044809

  • Kinesiology ambulatory recorder
Actiwatch 2 Dock Sub Assembly
Respironics, Inc.
Actiwatch 2 Dock Sub Assembly
In Commercial Distribution

  • 00606959043862 ()
1047045

  • Kinesiology ambulatory recorder
Actiwatch 2 Device
Respironics, Inc.
Actiwatch 2 Device
In Commercial Distribution

  • 00606959043855 ()
1043633

  • Kinesiology ambulatory recorder
Actiwatch 2 Docking Station
Respironics, Inc.
Actiwatch 2 Docking Station
In Commercial Distribution

  • 00606959042056 ()
1046977

  • Kinesiology ambulatory recorder
Actiwatch Spectrum Plus Japan
Respironics, Inc.
Actiwatch Spectrum Plus, Japan
Not in Commercial Distribution

  • 00606959042049 ()
JP1101894

  • Kinesiology ambulatory recorder
Actiwatch Spectrum PRO Japan
Respironics, Inc.
Actiwatch Spectrum PRO Japan
Not in Commercial Distribution

  • 00606959042032 ()
JP1099351

  • Kinesiology ambulatory recorder
Actiware Clinical Trial Software, English
Respironics, Inc.
Actiware Clinical Trial Software, English - 6
In Commercial Distribution

  • 00606959040366 ()
1103609

  • Kinesiology ambulatory recorder
Actiware Activity Analysis Software (for use with Actiwatch Activity Trackers)
Respironics, Inc.
Actiware Software Web Download - 6
In Commercial Distribution

  • 00606959039872 ()
1104776

  • Kinesiology ambulatory recorder
APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable.
APDM, INC.
V2C
In Commercial Distribution

  • B628OPALV2C0 ()
OPALV2C

  • Kinesiology ambulatory recorder
APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C.
APDM, INC.
V2C
In Commercial Distribution

  • B628DSV2C0 ()
DSV2C

  • Kinesiology ambulatory recorder
APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM, INC.
V2C
In Commercial Distribution

  • B628APV2C0 ()
APV2C

  • Kinesiology ambulatory recorder
Ambulatory Physical Activity Recorder with Electronic Patient diary
CAMNTECH LIMITED
PDV
In Commercial Distribution

  • B329PDV25 ()
05-121

  • Kinesiology ambulatory recorder
Ambulatory Physical Activity Recorder with Electronic Patient diary
CAMNTECH LIMITED
PDM
In Commercial Distribution

  • B329PDM25 ()
05-111

  • Kinesiology ambulatory recorder
Ambulatory Physical Activity Recorder
CAMNTECH LIMITED
MW-R
In Commercial Distribution

  • B329MWR50 ()
04-121

  • Kinesiology ambulatory recorder
Ambulatory Physical Activity Recorder
CAMNTECH LIMITED
MW8
In Commercial Distribution

  • B329MW850 ()
04-111

  • Kinesiology ambulatory recorder
Ambulatory Accelerometry recorder - triaxial
CAMNTECH LIMITED
Motion
Not in Commercial Distribution

  • B329AWVM33 ()
08-565

  • Kinesiology ambulatory recorder
No Description
Philips Medical Systems Hsg
989803196871
In Commercial Distribution

  • 20884838064960 ()
989803196871

  • Kinesiology ambulatory recorder
No Description
Philips Medical Systems Hsg
989803196861
In Commercial Distribution

  • 20884838064953 ()
989803196861

  • Kinesiology ambulatory recorder
The STERIS Harmony rSheild is a radiation proton device with 31.5-inch tube mounts to the STERIS Lighting Visualization Systems.
STERIS CORPORATION
rShield
In Commercial Distribution

  • 00724995153199 ()
LB58

  • Radiation shielding panel, fixed
The STERIS Harmony rSheild is a radiation proton device with 23.6-inch tube mounts to the STERIS Lighting Visualization Systems.
STERIS CORPORATION
rShield
In Commercial Distribution

  • 00724995153182 ()
LB56

  • Radiation shielding panel, fixed
L-Block Shield, 2" Lead, with 8" x 8" x 4" Lead Glass Window
BIODEX MEDICAL SYSTEMS, INC.
042-449
In Commercial Distribution

  • 00718175004494 ()
042-449

  • Radiation shielding panel, fixed
L-Block Shield, Compact, with Dose Calibrator Shield, 1.5" Lead
BIODEX MEDICAL SYSTEMS, INC.
042-433
In Commercial Distribution

  • 00718175004333 ()
042-433

  • Radiation shielding panel, fixed
L-Block Shield, 1.5" Lead, with 8" x 8" x 4" Lead Glass Window
BIODEX MEDICAL SYSTEMS, INC.
042-419
In Commercial Distribution

  • 00718175004197 ()
042-419

  • Radiation shielding panel, fixed
L-Block Shield, Deluxe, 2.4" Lead
BIODEX MEDICAL SYSTEMS, INC.
042-413
In Commercial Distribution

  • 00718175004135 ()
042-413

  • Radiation shielding panel, fixed
Glass, Lead, Plate, 12" x 12" x 8mm Thick
BIODEX MEDICAL SYSTEMS, INC.
042-228
In Commercial Distribution

  • 00718175002285 ()
042-228

  • Radiation shielding panel, fixed
Shield, Tabletop, Side, .25" Lead
BIODEX MEDICAL SYSTEMS, INC.
042-227
In Commercial Distribution

  • 00718175002278 ()
042-227

  • Radiation shielding panel, fixed
Shield, Tabletop, Bottom, .5" Lead
BIODEX MEDICAL SYSTEMS, INC.
042-226
In Commercial Distribution

  • 00718175002261 ()
042-226

  • Radiation shielding panel, fixed
Shield, Tabletop, Standard, .5" Lead
BIODEX MEDICAL SYSTEMS, INC.
042-224
In Commercial Distribution

  • 00718175002247 ()
042-224

  • Radiation shielding panel, fixed
SHIELD, BENCH TOP, GAMMA, ACRYLIC
BIODEX MEDICAL SYSTEMS, INC.
042-710
In Commercial Distribution

  • 00718175000144 ()
042-710

  • Radiation shielding panel, fixed
The EggNest Complete Shield is a scatter radiation protection shielding system. The intended purpose of the EggNest Complete Shield is to protect healthcare workers that are behind the shield in the x-ray procedure room from scatter radiation during medical procedures.
EGG Medical, Inc.
Complete
In Commercial Distribution

  • 00850067930020 ()


  • Radiation shielding panel, fixed
Optional lead shielding
NORTHSTAR MEDICAL RADIOISOTOPES, LLC
40010624
In Commercial Distribution

  • 00860002676418 ()
40010624

  • Radiation shielding panel, fixed
External lead shielding
NORTHSTAR MEDICAL RADIOISOTOPES, LLC
40010548
In Commercial Distribution

  • 00860002676401 ()
40010548

  • Radiation shielding panel, fixed
NEURO SHIELD W/CEILING TRACK
AADCO MEDICAL, INC.
OS-8128/OS-270
In Commercial Distribution

  • 00840348502275 ()
OS-8128/OS-270

  • Radiation shielding panel, fixed
NEURO SHIELD W/ARM AND COLUMN W/2 MORE ARMS FOR LIGHT AND SHIELD
AADCO MEDICAL, INC.
OS-8128-31
In Commercial Distribution

  • 00840348502268 ()
OS-8128-31

  • Radiation shielding panel, fixed
NEURO SHIELD
AADCO MEDICAL, INC.
OS-8128
In Commercial Distribution

  • 00840348502251 ()
OS-8128

  • Radiation shielding panel, fixed
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