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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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Cadwell - 00840067103487

UltraVision-XR Ultrasound System
CADWELL INDUSTRIES, INC.
190315-000
In Commercial Distribution

  • 00840067103487 ()


  • General-purpose ultrasound imaging system

T Lite - 03701104600321

Handheld Ultrasound Scanner T Lite Pro with exchangeables probes
SONOSCANNER
PRO
In Commercial Distribution

  • 03701104600321 ()


  • General-purpose ultrasound imaging system

U Lite - 03701104600291

Handheld Ultrasound Scanner U Lite Pro with exchangeables probes
SONOSCANNER
PRO
In Commercial Distribution

  • 03701104600291 ()


  • General-purpose ultrasound imaging system

UltraVision - B616UVXS0

General Purpose Diagnostic Medical Ultrasonic Imaging System
ULTRAVISION CORPORATION
XS
In Commercial Distribution

  • B616UVXS0 ()


  • General-purpose ultrasound imaging system

UltraVision - B616UVXR0

General Purpose Diagnostic Medical Ultrasonic Imaging System
ULTRAVISION CORPORATION
XR
In Commercial Distribution

  • B616UVXR0 ()


  • General-purpose ultrasound imaging system

UltraVision - B616UVXP0

General Purpose Diagnostic Medical Ultrasonic Imaging System
ULTRAVISION CORPORATION
XP
In Commercial Distribution

  • B616UVXP0 ()


  • General-purpose ultrasound imaging system

UltraVision - B616UVXC0

General Purpose Diagnostic Ultrasonic Imaging System
ULTRAVISION CORPORATION
XC
In Commercial Distribution

  • B616UVXC0 ()


  • General-purpose ultrasound imaging system

Kidney KFRE Algorithm - 07613336223321

No Description
Roche Diagnostics GmbH
09891986001
In Commercial Distribution

  • 07613336223321 ()
09891986001

  • Clinical management support software IVD

MEDISONO - B369MUS05253

Probe
Medisono, LLC
PENCIL PROBE MODEL PB-CWD 2.0 FOR MEDISONO MS12
In Commercial Distribution

  • B369MUS05253 ()


  • General-purpose ultrasound imaging system

MEDISONO - B369MUS05252

Probe
Medisono, LLC
PHASED ARRAY PROBE MODEL 7P-B FOR MEDISONO MS12
In Commercial Distribution

  • B369MUS05252 ()


  • General-purpose ultrasound imaging system

MEDISONO - B369MUS05251

Probe
Medisono, LLC
PHASED ARRAY PROBE MODEL P3-A FOR MEDISONO MS12
In Commercial Distribution

  • B369MUS05251 ()


  • General-purpose ultrasound imaging system

MEDISONO - B369MUS05250

Probe
Medisono, LLC
LINEAR ARRAY PROBE MODEL PB-9L-A FOR MEDISONO MS12
In Commercial Distribution

  • B369MUS05250 ()


  • General-purpose ultrasound imaging system

MEDISONO - B369MUS05249

INTRAOPERATIVE MODEL PB-6CT-A FOR MEDISONO MS12EXP
Medisono, LLC
INTRAOPERATIVE MODEL PB-6CT-A FOR MEDISONO MS12EXP
In Commercial Distribution

  • B369MUS05249 ()
MUS05249

  • General-purpose ultrasound imaging system

MEDISONO - B369MUS05248

LINEAR ARRAY (INTRAOPERATIVE) PROBE MODEL PB-10I2 FOR MEDISONO MS12EXP
Medisono, LLC
LINEAR ARRAY (INTRAOPERATIVE) PROBE MODEL PB-10I2 FOR MEDISONO MS12EXP
In Commercial Distribution

  • B369MUS05248 ()
MUS05248

  • General-purpose ultrasound imaging system

MEDISONO - B369MUS05247

ENDOCAVITY CONVEX ARRAY PROBE MODEL EC9-5 FOR MEDISONO MS12EXP
Medisono, LLC
ENDOCAVITY CONVEX ARRAY PROBE MODEL EC9-5 FOR MEDISONO MS12EXP
In Commercial Distribution

  • B369MUS05247 ()
MUS05247

  • General-purpose ultrasound imaging system

MEDISONO - B369MUS05246

ENDOCAVITY ARRAY PROBE MODEL PB-6V1 FOR MEDISONO MS12EXP
Medisono, LLC
ENDOCAVITY ARRAY PROBE MODEL PB-6V1 FOR MEDISONO MS12EXP
In Commercial Distribution

  • B369MUS05246 ()
MUS05246

  • General-purpose ultrasound imaging system

MEDISONO - B369MUS05245

MICRO-CONVEX ARRAY PROBE MODEL PB-C613 FOR MEDISONO MS12EXP
Medisono, LLC
MICRO-CONVEX ARRAY PROBE MODEL PB-C613 FOR MEDISONO MS12EXP
In Commercial Distribution

  • B369MUS05245 ()
MUS05245

  • General-purpose ultrasound imaging system

MEDISONO - B369MUS05244

CONVEX ARRAY PROBE MODEL PB-C361 FOR MEDISONO MS12EXP
Medisono, LLC
CONVEX ARRAY PROBE MODEL PB-C361 FOR MEDISONO MS12EXP
In Commercial Distribution

  • B369MUS05244 ()
MUS05244

  • General-purpose ultrasound imaging system

MEDISONO - B369MUS05243

CONVEX ARRAY PROBE MODEL PB-C322 FOR MEDISONO MS12EXP
Medisono, LLC
CONVEX ARRAY PROBE MODEL PB-C322 FOR MEDISONO MS12EXP
In Commercial Distribution

  • B369MUS05243 ()
MUS05243

  • General-purpose ultrasound imaging system

MEDISONO - B369MUS05242

CONVEX PROBE MODEL PB-3C-A FOR MEDISONO MS12EXP
Medisono, LLC
CONVEX PROBE MODEL PB-3C-A FOR MEDISONO MS12EXP
In Commercial Distribution

  • B369MUS05242 ()
MUS05242

  • General-purpose ultrasound imaging system
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