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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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RESIGHT 500 - 04049539072023

No Description
Carl Zeiss Meditec AG
302721-9020-000
In Commercial Distribution

  • 04049539072023 ()


  • Ophthalmic fundus camera

Tenovi - G004TCCBP010

Tenovi Cellular Blood Pressure Monitor
Tenovi Co.
TC-CBP-01
In Commercial Distribution

  • G004TCCBP010 ()


  • Telemetric sphygmomanometer

Tenovi - G004TCBPMS20

Tenovi Bluetooth Blood Pressure Monitor - Small Cuff Size
Tenovi Co.
TC-BPM-S2
In Commercial Distribution

  • G004TCBPMS20 ()


  • Telemetric sphygmomanometer

Tenovi - G004TCBPML20

Tenovi Bluetooth Blood Pressure Monitor - Large Cuff Size
Tenovi Co.
TC-BPM-L2
In Commercial Distribution

  • G004TCBPML20 ()


  • Telemetric sphygmomanometer

Tenovi - G004TCBPMA20

Bluetooth Blood Pressure Monitor
Tenovi Co.
TC-BPM-A2
In Commercial Distribution

  • G004TCBPMA20 ()


  • Telemetric sphygmomanometer

Tenovi - G004TCBPMA10

Bluetooth Blood Pressure Monitor
Tenovi Co.
TC-BPM-A1
In Commercial Distribution

  • G004TCBPMA10 ()


  • Telemetric sphygmomanometer

CM04 - 07640132987690

No Description
Haag-Streit AG
30/70 IM910
In Commercial Distribution

  • 07640132987690 ()
1023835

  • Ophthalmic fundus camera

CM04 - 07640132987669

No Description
Haag-Streit AG
IM 910
In Commercial Distribution

  • 07640132987669 ()
1023138

  • Ophthalmic fundus camera

Bowman Perfusion Monitor, 240V - B238H000107110

Perfusion Monitor, 240V
HEMEDEX, INC
Model 500
In Commercial Distribution

  • B238H000107110 ()
H0001-0711

  • Patient monitoring system module, intracranial pressure

QFlow 500 Perfusion Probe - B238H000016000

Thermal Diffusion Probe
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000016000 ()
H0000-1600

  • Patient monitoring system module, intracranial pressure

Bowman Perfusion Monitor, 120V - B238H000007100

Perfusion Monitor, 120V
HEMEDEX, INC
Model 500
In Commercial Distribution

  • B238H000007100 ()
H0000-0710

  • Patient monitoring system module, intracranial pressure

iNview for iPhone 6 (VINVIEW-6) - 00811608018898

No Description
VOLK OPTICAL INC.
VINVIEW-6
In Commercial Distribution

  • 00811608018898 ()


  • Ophthalmic fundus camera

iNview for iPhone 5s (VINVIEW-5S) - 00811608018881

No Description
VOLK OPTICAL INC.
VINVIEW-5S
In Commercial Distribution

  • 00811608018881 ()


  • Ophthalmic fundus camera

Volk Pictor VP1Handset, VP1RET, VP1ANT, VP1OTO, & VP1DERM - 00811608018065

No Description
VOLK OPTICAL INC.
VP1COMPK
In Commercial Distribution

  • 00811608018065 ()


  • Ophthalmic fundus camera

Volk Pictor VP1Handset, VP1RET - 00811608017969

No Description
VOLK OPTICAL INC.
VP1RETK
In Commercial Distribution

  • 00811608017969 ()


  • Ophthalmic fundus camera

Volk Pictor VP1RET - 00811608017815

No Description
VOLK OPTICAL INC.
VP1RET
In Commercial Distribution

  • 00811608017815 ()


  • Ophthalmic fundus camera

Volk Pictor VP1Handset - 00811608017808

No Description
VOLK OPTICAL INC.
VP1HAND
In Commercial Distribution

  • 00811608017808 ()


  • Ophthalmic fundus camera

Volk Pictor Plus VP2FA - 00811608018706

No Description
VOLK OPTICAL INC.
VP2FA
In Commercial Distribution

  • 00811608018706 ()


  • Ophthalmic fundus camera

Volk Pictor Plus VP2HAND, VP2RET and VP2ANT - 00811608018638

No Description
VOLK OPTICAL INC.
VP2OPHK
In Commercial Distribution

  • 00811608018638 ()


  • Ophthalmic fundus camera

Volk Pictor Plus VP2HAND and VP2ANT - 00811608018621

No Description
VOLK OPTICAL INC.
VP2ANTK
In Commercial Distribution

  • 00811608018621 ()


  • Ophthalmic fundus camera
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