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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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bk3000, bk3500, bk5000, bkActiv - 05704916000264

ULTRASOUND SYSTEM
Bk Medical ApS
2300
In Commercial Distribution

  • 05704916000264 ()


  • General-purpose ultrasound imaging system

I-Streme Echo Ultrasound System - 00850921007219

I-STREME ECHO ULTRASOUND SYSTEM with Linear Array Probe
INTERSON CORP
1
In Commercial Distribution

  • 00850921007219 ()


  • General-purpose ultrasound imaging system

Ultrasound System, ZS3 - 00851315007211

ZS3 - SP Diagnostic Ultrasound System
ZONARE MEDICAL SYSTEMS, INC.
ZS3-SP
Not in Commercial Distribution

  • 00851315007211 ()


  • General-purpose ultrasound imaging system

Ultrasound System, Z.One PRO - 00851315007013

Diagnostic Ultrasound System
ZONARE MEDICAL SYSTEMS, INC.
Z.One PRO
Not in Commercial Distribution

  • 00851315007013 ()


  • General-purpose ultrasound imaging system

Ultrasound System, ZS3 - 00851315007006

Diagnostic Ultrasound System
ZONARE MEDICAL SYSTEMS, INC.
ZS3
Not in Commercial Distribution

  • 00851315007006 ()


  • General-purpose ultrasound imaging system

Sepsis ImmunoScore - 00860013516208

No Description
Prenosis, Inc.
1.5.0
In Commercial Distribution

  • 00860013516208 ()


  • Clinical management support software IVD

uREzpocus - 00866955000492

Linear probe.
Norland at Swissray
uREzpocus L
In Commercial Distribution

  • 00866955000492 ()


  • General-purpose ultrasound imaging system

uREzpocus - 00866955000485

Convex probe.
Norland at Swissray
uREzpocus C
In Commercial Distribution

  • 00866955000485 ()


  • General-purpose ultrasound imaging system

uREzpocus - 00860008461223

Ultrasonic pulsed doppler imaging system - MicroConvex array
Norland at Swissray
uREzpocus M
In Commercial Distribution

  • 00860008461223 ()


  • General-purpose ultrasound imaging system

uREzpocus - 00860008461216

Ultrasonic pulsed doppler imaging system - uREzpocus H
Norland at Swissray
uREzpocus H
In Commercial Distribution

  • 00860008461216 ()


  • General-purpose ultrasound imaging system

Bot Image, Inc. - 00860009082625

ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted GE Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082625 ()


  • MRI image interpretive software

Bot Image, Inc. - 00860009082618

ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted On-Premise
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082618 ()
580SW.01

  • MRI image interpretive software

Bot Image, Inc. - 00860009082601

ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted Terrarecon Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082601 ()


  • MRI image interpretive software

Halo Med. Technologies - 00860008657886

Catalyst Ultrasound System -Portable
Halo Medical Technologies, LLC
HMT MCP
In Commercial Distribution

  • 00860008657886 ()


  • General-purpose ultrasound imaging system

Halo Medical Technologies - 00860008657381

Curved Array Probe
Halo Medical Technologies, LLC
HMT-SURM
In Commercial Distribution

  • 00860008657381 ()


  • General-purpose ultrasound imaging system

Halo Medical Technologies - 00860008657312

Catalyst Ultrasound System - Conventional
Halo Medical Technologies, LLC
HMT-LTSYS
In Commercial Distribution

  • 00860008657312 ()


  • General-purpose ultrasound imaging system

Halo Medical Technologies - 00860008657305

Catalyst Ultrasound System -Portable
Halo Medical Technologies, LLC
HMT-AIOSYS
In Commercial Distribution

  • 00860008657305 ()


  • General-purpose ultrasound imaging system

uREzpocus - 00860008461209

Ultrasonic pulsed doppler imaging system - Convex HD array
Norland at Swissray
uREzpocus C-EMS
In Commercial Distribution

  • 00860008461209 ()


  • General-purpose ultrasound imaging system

Butterfly Network, Inc. - 00866646000206

Portable Ultrasound System
BUTTERFLY NETWORK, INC.
Butterfly iQ
In Commercial Distribution

  • 00866646000206 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396488017

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
CTS-8800 Plus
In Commercial Distribution

  • 06938396488017 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396431020

Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
CTS-310B
In Commercial Distribution

  • 06938396431020 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396421007

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 2100
In Commercial Distribution

  • 06938396421007 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396412005

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1200
In Commercial Distribution

  • 06938396412005 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396410094

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1000B/W
In Commercial Distribution

  • 06938396410094 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396410087

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1000Exp
In Commercial Distribution

  • 06938396410087 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396410070

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1000Neo
In Commercial Distribution

  • 06938396410070 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396410056

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1000Lite
In Commercial Distribution

  • 06938396410056 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396410001

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1000
In Commercial Distribution

  • 06938396410001 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396401382

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee K2
In Commercial Distribution

  • 06938396401382 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396401368

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee C5
In Commercial Distribution

  • 06938396401368 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396401344

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee C2
In Commercial Distribution

  • 06938396401344 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396401078

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius C3
In Commercial Distribution

  • 06938396401078 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396401054

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius V5
In Commercial Distribution

  • 06938396401054 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396401030

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius P3
In Commercial Distribution

  • 06938396401030 ()


  • General-purpose ultrasound imaging system

Power Park - 00841517106348

No Description
FUJIFILM SONOSITE, INC.
P25003-15
In Commercial Distribution

  • 00841517106348 ()
P25003

  • General-purpose ultrasound imaging system

Sonosite PX Stand Head - 00841517106331

Sonosite PX Stand Head
FUJIFILM SONOSITE, INC.
P25001-16
In Commercial Distribution

  • 00841517106331 ()
P25001

  • General-purpose ultrasound imaging system

SONOSITE PX ULTRASOUND SYSTEM - 00841517106324

SONOSITE PX ULTRASOUND SYSTEM
FUJIFILM SONOSITE, INC.
P25000-20
In Commercial Distribution

  • 00841517106324 ()
P25000

  • General-purpose ultrasound imaging system

Sonosite PX - 00841517106034

No Description
FUJIFILM SONOSITE, INC.
P25000-18
In Commercial Distribution

  • 00841517106034 ()
P25000

  • General-purpose ultrasound imaging system

Sonosite PX - 00841517106027

No Description
FUJIFILM SONOSITE, INC.
P25000-17
In Commercial Distribution

  • 00841517106027 ()
P25000

  • General-purpose ultrasound imaging system

Sonosite PX Stand Battery - 00841517105945

Stand Battery for PX Ultrasound system.
FUJIFILM SONOSITE, INC.
P27003-17
In Commercial Distribution

  • 00841517105945 ()
P27003

  • General-purpose ultrasound imaging system
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