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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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Mediblu - B632MDB01034

No Description
MEDIBLU MEDICAL LLC
BLU 12+
In Commercial Distribution

  • B632MDB01034 ()
MDB01034

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01028

No Description
MEDIBLU MEDICAL LLC
BLU 12
In Commercial Distribution

  • B632MDB01028 ()
MDB01028

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01004

No Description
MEDIBLU MEDICAL LLC
MM5
In Commercial Distribution

  • B632MDB01004 ()
MDB01004

  • Multiple vital physiological parameter monitoring system, clinical

QVCAD System Installation Kit - B630QVCSIK1202346

Installation Kit for QVCAD System Release 3.4.6 with Debian 12.2
QVIEW MEDICAL
12.02-3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System Installation Kit - B630QVCSIK1010344

Installation Kit for QVCAD System Release 3.4.4 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System Installation Kit - B630QVCSIK1010343

Installation Kit for QVCAD System Release 3.4.3 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.3
In Commercial Distribution

  • B630QVCSIK1010343 ()


  • Ultrasound imaging system application software

QVCAD System - B630QVCS346

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS344

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS343

No Description
QVIEW MEDICAL
3.4.3
In Commercial Distribution

  • B630QVCS343 ()


  • Ultrasound imaging system application software

QVCAD System - B630QVCS342

No Description
QVIEW MEDICAL
3.4.2
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS34

No Description
QVIEW MEDICAL
3.4
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS33

No Description
QVIEW MEDICAL
3.3
In Commercial Distribution

  • B630QVCS33 ()


  • Ultrasound imaging system application software

Omni™ Surgical Suite Platform - 00889024647343

No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1000
In Commercial Distribution

  • 00889024647343 ()
AI1000

  • Medical image management system

Omni™ Surgical Suite - 00889024624887

No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1019
In Commercial Distribution

  • 00889024624887 ()
AI1019

  • Medical image management system

Omni™ Surgical Suite Platform - 00889024596184

No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1000
In Commercial Distribution

  • 00889024596184 ()
AI1000

  • Medical image management system

Visualize:Vascular - B725INITVV12

Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging.
SALIENT IMAGING
1.2
In Commercial Distribution

  • B725INITVV1 ()
  • B725INITVV12 ()
INITVV

  • Ultrasound imaging system application software

Mediblu - B632MDB01007

No Description
MEDIBLU MEDICAL LLC
FM10
In Commercial Distribution

  • B632MDB01007 ()
MDB01007

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01005

No Description
MEDIBLU MEDICAL LLC
MM3
In Commercial Distribution

  • B632MDB01005 ()
MDB01005

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01003

No Description
MEDIBLU MEDICAL LLC
MM12
In Commercial Distribution

  • B632MDB01003 ()
MDB01003

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01002

No Description
MEDIBLU MEDICAL LLC
MM15
In Commercial Distribution

  • B632MDB01002 ()
MDB01002

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01001

No Description
MEDIBLU MEDICAL LLC
MM17
In Commercial Distribution

  • B632MDB01001 ()
MDB01001

  • Multiple vital physiological parameter monitoring system, clinical

Surveyor Central - 00817655022550

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-AAA-AOBEX
Not in Commercial Distribution

  • 00817655022550 ()


  • Centralized patient monitor

Surveyor Central - 00817655022147

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-DAA-BXXEX
Not in Commercial Distribution

  • 00817655022147 ()


  • Centralized patient monitor

Surveyor Central - 00817655022109

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-DAA-BXBEX
Not in Commercial Distribution

  • 00817655022109 ()


  • Centralized patient monitor

Surveyor Central - 00817655022093

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-CAA-BXBEX
Not in Commercial Distribution

  • 00817655022093 ()


  • Centralized patient monitor

Surveyor S19 - 00817655022017

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-SAA-XXXAX
Not in Commercial Distribution

  • 00817655022017 ()


  • Centralized patient monitor

Surveyor Central - 00817655021942

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCSYS-HAE-SHFCX
Not in Commercial Distribution

  • 00817655021942 ()


  • Centralized patient monitor

Surveyor S19 - 00817655021928

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-LAA-XXXAX
Not in Commercial Distribution

  • 00817655021928 ()


  • Centralized patient monitor

Surveyor Central - 00817655021874

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-AAA-DXBEX
Not in Commercial Distribution

  • 00817655021874 ()


  • Centralized patient monitor

Surveyor Central - 00817655021065

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-BAA-AKXEX
Not in Commercial Distribution

  • 00817655021065 ()


  • Centralized patient monitor
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