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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No Description
Roche Diagnostics GmbH
07027028190
Not in Commercial Distribution

  • 04015630939640 ()
07027028190

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
Calcium Reagent Kit for use with EasyRA Analyzers
MEDICA CORPORATION
10210-4
In Commercial Distribution

  • 00386100002060 ()
10210-4

  • Calcium (Ca2+) IVD, kit, spectrophotometry
The product is applied to calibrate the sensitivity of LEDs used for blood coagulation analyzer.
SYSMEX CORPORATION
014-1271-4
In Commercial Distribution

  • 14987562516794 ()
  • 04987562516797 ()


  • Multiple coagulation factor IVD, calibrator
Series 3, 500 DT, Single CA,N/A, Single CA, 850mm, 850mm, Gen 2, Sgl M SA, MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007732 ()
C35SBS2211

  • Operating room light
S3,300DT,Sgl CA,Dl CA,SgCA,1300 1150 1000 1300, SgMH Sony,(N3P, DY,3PLH) Sg MH S
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007671 ()
C33SDS5435N33N

  • Operating room light
S3 Sgl CA Dual CA 1300,1150,1000 9P SA DY 30M 9P SA DY 30M 3P SA DY 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001051 ()
C33SDB543535

  • Operating room light
NEURO-ARM SYSTEM W CLAMP HOLDING ADAPTER
GEOMED Medizin-Technik GmbH & Co. KG
CA 450-40-01
In Commercial Distribution

  • 14049679092957 ()


  • Surgical instrument assist arm system, manually-adjusted
No Description
PROSOMNUS SLEEP TECHNOLOGIES
CA Monitor
In Commercial Distribution

  • 00863039000454 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
S3 300DT 2x Sgl 1x Dual CA 2x 1300 1150 1000 CA 3P 30M 9P 30M 2x Barco Monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006438 ()
C33SDS554335KK

  • Operating room light
S3 300DT 3x Sgl CA 1xDual CA 1300 1150 1000 1300 2x LCH 3P 1x9P LCH 1x Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003741 ()
C33SDS54354614

  • Operating room light
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