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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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Millennium - 00190776166472

MODULAR WEIGHT
Avalign Technologies, Inc.
1-343001
In Commercial Distribution

  • 00190776166472 ()


  • Telemetric sphygmomanometer

Millennium - 00190776166458

Hohmann Retr . Blade
Avalign Technologies, Inc.
1-34160002
In Commercial Distribution

  • 00190776166458 ()


  • Telemetric sphygmomanometer

Millennium - 00190776166441

DEAVER RETRACTOR, . Blade
Avalign Technologies, Inc.
1-3317
In Commercial Distribution

  • 00190776166441 ()


  • Telemetric sphygmomanometer

Millennium - 00190776166434

McBride Retr Toothed Shank Cust Speed Lock
Avalign Technologies, Inc.
1-3316CSL
In Commercial Distribution

  • 00190776166434 ()


  • Telemetric sphygmomanometer

Millennium - 00190776166427

DE LEE UNIVERSAL RETRACTOR . BLADE .
Avalign Technologies, Inc.
1-30340
In Commercial Distribution

  • 00190776166427 ()


  • Telemetric sphygmomanometer

Millennium - 00190776166410

Unger Wide Hohmann with Two Tips Blade
Avalign Technologies, Inc.
1-3008
In Commercial Distribution

  • 00190776166410 ()


  • Telemetric sphygmomanometer

Millennium - 00190776166403

Finochietto Rib Retr Infant wit
Avalign Technologies, Inc.
1-300200
In Commercial Distribution

  • 00190776166403 ()


  • Telemetric sphygmomanometer

Millennium - 00190776166397

Unger Narrow Hohmann Blade wide
Avalign Technologies, Inc.
1-3002
In Commercial Distribution

  • 00190776166397 ()


  • Telemetric sphygmomanometer

Millennium - 00190776384869

Double Ended Orbital Retractor, large, 16mm/ 25mm
Avalign Technologies, Inc.
1-3705
In Commercial Distribution

  • 00190776384869 ()


  • Telemetric sphygmomanometer

Millennium - 00190776384845

Desmarres Lid Retractor, 5 1/2", 15mm, coated
Avalign Technologies, Inc.
1-210196NC
In Commercial Distribution

  • 00190776384845 ()


  • Telemetric sphygmomanometer

Millennium - 00190776402730

Unger Hohmann, Narrow Blade 34mm, 5.5" blade depth
Avalign Technologies, Inc.
1-3002M
In Commercial Distribution

  • 00190776402730 ()


  • Telemetric sphygmomanometer

Tel-O-Graph - 04041346102160

LTE 4G capable
IEM GmbH
GSM plus
In Commercial Distribution

  • 04041346102160 ()


  • Telemetric sphygmomanometer

Tel-O-Graph - 04041346101279

No Description
IEM GmbH
BT plus
In Commercial Distribution

  • 04041346101279 ()


  • Telemetric sphygmomanometer

Tel-O-Graph - 04041346101262

No Description
IEM GmbH
GSM plus
In Commercial Distribution

  • 04041346101262 ()


  • Telemetric sphygmomanometer

SBPM cuff - 04041346101231

No Description
IEM GmbH
size XL
In Commercial Distribution

  • 04041346101231 ()


  • Telemetric sphygmomanometer

SBPM cuff - 04041346101224

No Description
IEM GmbH
size L
In Commercial Distribution

  • 04041346101224 ()


  • Telemetric sphygmomanometer

SBPM cuff - 04041346101217

No Description
IEM GmbH
size M
In Commercial Distribution

  • 04041346101217 ()


  • Telemetric sphygmomanometer

SBPM cuff - 04041346101200

No Description
IEM GmbH
size S
In Commercial Distribution

  • 04041346101200 ()


  • Telemetric sphygmomanometer

Millennium - 00190776397494

Desmarres Lid Retractor, size 4, 18mmn, 5 1/2"
Avalign Technologies, Inc.
1-350153
In Commercial Distribution

  • 00190776397494 ()


  • Telemetric sphygmomanometer

SOPHYSA - 03760124131512

PRESSIO SERIAL TRANSMITTER
SOPHYSA
PSO-TX00
Not in Commercial Distribution

  • 03760124131512 ()


  • Patient monitoring system module, intracranial pressure

SOPHYSA - 03760124131499

PRESSIO ICP INTERFACE CONTROL UNIT
SOPHYSA
PSO-IN00
Not in Commercial Distribution

  • 03760124131499 ()


  • Patient monitoring system module, intracranial pressure

Core Cognitive Evaluation - B626200050

No Description
Linus Health, Inc.
20005
In Commercial Distribution

  • B626200050 ()
20005

  • Cognitive assessment software

Research Platform - B626200020

No Description
Linus Health, Inc.
20002
Not in Commercial Distribution

  • B626200020 ()


  • Cognitive assessment software

Core Cognitive Evaluation - B626200010

Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It is intended to be used by medical professionals qualified to interpret results of a cognitive assessment.
Linus Health, Inc.
20001
Not in Commercial Distribution

  • B626200010 ()
20001

  • Cognitive assessment software

Buxton BioMedical - B7687211010

Penfield 1 Cup/Dissector
Buxton Biomedical Inc
72-1101
In Commercial Distribution

  • B7687211010 ()
72-1101

  • Telemetric sphygmomanometer

PROTOZ - B667PROTOZ1

ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent) with different outline colors.
NEXT SIGHT SRL
01
In Commercial Distribution

  • B667PROTOZ01 ()
  • B667PROTOZ1 ()


  • Ophthalmic fundus camera

NEXY - B667NEXY1

Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.
NEXT SIGHT SRL
01
In Commercial Distribution

  • B667NEXY01 ()
  • B667NEXY1 ()


  • Ophthalmic fundus camera

Eyer 2 Basic - 07908616100097

Eyer 2 Basic
PHELCOM TECHNOLOGIES SA
Eyer 2 Basic
In Commercial Distribution

  • 07908616100097 ()


  • Ophthalmic fundus camera

Eyer - 07908616100042

Eyer Retinal Camera M-STD
PHELCOM TECHNOLOGIES SA
Eyer M-STD
In Commercial Distribution

  • 07908616100042 ()
M-STD

  • Ophthalmic fundus camera

Eyer - 07908616100011

Eyer Retinal Camera NM-STD
PHELCOM TECHNOLOGIES SA
Eyer NM-STD
In Commercial Distribution

  • 07908616100011 ()
NM-STD

  • Ophthalmic fundus camera

iNview Touch Camera (VINVIEWC-TCH) - 00811608018911

No Description
VOLK OPTICAL INC.
VINVIEWC-TCH
In Commercial Distribution

  • 00811608018911 ()


  • Ophthalmic fundus camera

iNview for iPod Touch (VINVIEW-TCH) - 00811608018904

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

  • 00811608018904 ()


  • Ophthalmic fundus camera

Volk Viva - 00811608014739

No Description
VOLK OPTICAL INC.
VVIVA1B
In Commercial Distribution

  • 00811608014739 ()


  • Ophthalmic fundus camera

Volk Viva - 00811608014708

No Description
VOLK OPTICAL INC.
VVIVA1A
In Commercial Distribution

  • 00811608014708 ()


  • Ophthalmic fundus camera

VistaView Slit Lamp Adapter - 00811608014586

No Description
VOLK OPTICAL INC.
VVISTAVIEW2SLA
In Commercial Distribution

  • 00811608014586 ()


  • Ophthalmic fundus camera

Volk VistaView - 00811608013770

No Description
VOLK OPTICAL INC.
VVISTAVIEW2
In Commercial Distribution

  • 00811608013770 ()


  • Ophthalmic fundus camera

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 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

Volk Pictor Plus VP2HAND AND VP2RET - 00811608018614

No Description
VOLK OPTICAL INC.
VP2RETK
In Commercial Distribution

  • 00811608018614 ()


  • Ophthalmic fundus camera

Volk Pictor Plus VP2ANT - 00811608018577

No Description
VOLK OPTICAL INC.
VP2ANT
In Commercial Distribution

  • 00811608018577 ()


  • Ophthalmic fundus camera

Volk Pictor Plus VP2RET - 00811608018560

No Description
VOLK OPTICAL INC.
VP2RET
In Commercial Distribution

  • 00811608018560 ()


  • 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 and VP1ANT - 00811608018003

No Description
VOLK OPTICAL INC.
VP1OPHK
In Commercial Distribution

  • 00811608018003 ()


  • Ophthalmic fundus camera

Volk Pictor VP1Handset, VP1RET - 00811608017969

No Description
VOLK OPTICAL INC.
VP1RETK
In Commercial Distribution

  • 00811608017969 ()


  • Ophthalmic fundus camera

Volk Pictor VP1ANT - 00811608017822

No Description
VOLK OPTICAL INC.
VP1ANT
In Commercial Distribution

  • 00811608017822 ()


  • 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
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