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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GRAFT SIZER
STRYKER CORPORATION
2000-004-051
In Commercial Distribution

  • 04546540790989 ()
2000-004-051

  • Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 8MM
STRYKER CORPORATION
234-020-087
In Commercial Distribution

  • 04546540755889 ()

  • Lumen/Inner Diameter: 8.0 Millimeter
234-020-087

  • Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 7MM
STRYKER CORPORATION
234-020-086
In Commercial Distribution

  • 04546540755872 ()

  • Lumen/Inner Diameter: 7.0 Millimeter
234-020-086

  • Ligament graft sizer, noninvasive
GRAFT SIZING GAUGE 6MM
STRYKER CORPORATION
234-020-085
In Commercial Distribution

  • 04546540755865 ()

  • Lumen/Inner Diameter: 6.0 Millimeter
234-020-085

  • Ligament graft sizer, noninvasive
DRILL GUIDE/GRAFT SIZER, MODULAR ACL WORKSTATION
STRYKER CORPORATION
234-010-517
In Commercial Distribution

  • 04546540755124 ()
234-010-517

  • Ligament graft sizer, noninvasive
13MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-514
In Commercial Distribution

  • 04546540755094 ()

  • Lumen/Inner Diameter: 13.0 Millimeter
234-010-514

  • Ligament graft sizer, noninvasive
12.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-513
In Commercial Distribution

  • 04546540755087 ()

  • Lumen/Inner Diameter: 12.5 Millimeter
234-010-513

  • Ligament graft sizer, noninvasive
11.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-512
In Commercial Distribution

  • 04546540755070 ()

  • Lumen/Inner Diameter: 11.5 Millimeter
234-010-512

  • Ligament graft sizer, noninvasive
10.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-511
In Commercial Distribution

  • 04546540755063 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
234-010-511

  • Ligament graft sizer, noninvasive
9.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-510
In Commercial Distribution

  • 04546540755056 ()

  • Lumen/Inner Diameter: 9.5 Millimeter
234-010-510

  • Ligament graft sizer, noninvasive
8.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-509
In Commercial Distribution

  • 04546540755049 ()

  • Lumen/Inner Diameter: 8.5 Millimeter
234-010-509

  • Ligament graft sizer, noninvasive
7.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-508
In Commercial Distribution

  • 04546540755032 ()

  • Lumen/Inner Diameter: 7.5 Millimeter
234-010-508

  • Ligament graft sizer, noninvasive
6.5MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-507
In Commercial Distribution

  • 04546540755025 ()

  • Lumen/Inner Diameter: 6.5 Millimeter
234-010-507

  • Ligament graft sizer, noninvasive
12MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-005
In Commercial Distribution

  • 04546540754417 ()

  • Lumen/Inner Diameter: 12.0 Millimeter
234-010-005

  • Ligament graft sizer, noninvasive
11MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-004
In Commercial Distribution

  • 04546540754400 ()

  • Lumen/Inner Diameter: 11.0 Millimeter
234-010-004

  • Ligament graft sizer, noninvasive
10MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-003
In Commercial Distribution

  • 04546540754394 ()

  • Lumen/Inner Diameter: 10.0 Millimeter
234-010-003

  • Ligament graft sizer, noninvasive
9MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-002
In Commercial Distribution

  • 04546540754387 ()

  • Lumen/Inner Diameter: 9.0 Millimeter
234-010-002

  • Ligament graft sizer, noninvasive
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V2.0
Not in Commercial Distribution

  • 05060878810052 ()


  • Ultrasound imaging system application software
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V1.1
Not in Commercial Distribution

  • 05060878810021 ()


  • Ultrasound imaging system application software
Angio Workstation Software
CANON MEDICAL SYSTEMS CORPORATION
XIDF-AWS801
In Commercial Distribution

  • 04987670100451 ()


  • Diagnostic x-ray digital imaging system workstation application software
LIGAMENT SIZING SCALE 0 - 13mm (Plus or Minus 3 Percent)
DEPUY MITEK, LLC
232013
Not in Commercial Distribution

  • 10886705010943 ()
232013

  • Ligament graft sizer, noninvasive
RESTORE GRAFT SIZER 8-12mm (Plus or Minus 2 Percent)
Medos International Sàrl
232015
In Commercial Distribution

  • 10886705010950 ()
232015

  • Ligament graft sizer, noninvasive
Tendon and Graft Sizer 4-9mm Plus or Minus 3 Percent
Medos International Sàrl
219445
In Commercial Distribution

  • 10886705006519 ()
219445

  • Ligament graft sizer, noninvasive
GRAFT SIZER 5-12mm Plus or Minus 3 Percent
Medos International Sàrl
219444
In Commercial Distribution

  • 10886705006502 ()
219444

  • Ligament graft sizer, noninvasive
MITEK TIGHT-N Tendon Docking Anchor Implant Sizer
Medos International Sàrl
208886
In Commercial Distribution

  • 10886705032716 ()
208886

  • Ligament graft sizer, noninvasive
Tendon Thickness Tester, 4-7 mm
Karl Storz GmbH & Co. KG
28729SD
In Commercial Distribution

  • 04048551114728 ()


  • Ligament graft sizer, noninvasive
Tendon Thickness Tester, 6-10.5 mm
Karl Storz GmbH & Co. KG
28729SA
In Commercial Distribution

  • 04048551114698 ()


  • Ligament graft sizer, noninvasive
Measuring Block
Karl Storz GmbH & Co. KG
28729PH
In Commercial Distribution

  • 04048551114575 ()


  • Ligament graft sizer, noninvasive
Tendon Thickness Tester, 7-12 mm
Karl Storz GmbH & Co. KG
28729SE
In Commercial Distribution

  • 04048551008287 ()


  • Ligament graft sizer, noninvasive
Tendon Thickness Tester
Karl Storz GmbH & Co. KG
28185MB
In Commercial Distribution

  • 04048551310373 ()


  • Ligament graft sizer, noninvasive
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software
No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution

  • 00850011790199 ()
MREPLUSV3

  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution

  • 00850011790014 ()


  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution

  • 00850011790007 ()


  • MRI system application software
Software Upgrade Kitv.3.0.1.1
ST. JUDE MEDICAL, INC.
H21921
In Commercial Distribution

  • 05414734219211 ()
H21921

  • Cardiac mapping system application software
No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214841 ()
75-06066-001

  • Cardiac mapping system application software
No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214636 ()
75-05772-001

  • Cardiac mapping system application software
AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion Indications for use: AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution

  • 05600250059022 ()


  • MRI system application software
WBR Imaging X + X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177121 ()


  • SPECT system application software
WBR Imaging X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177114 ()


  • SPECT system application software
WBR Imaging X + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177107 ()


  • SPECT system application software
WBR Imaging X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177053 ()


  • SPECT system application software
WBR Imaging X + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177046 ()


  • SPECT system application software
WBR Imaging Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177039 ()


  • SPECT system application software
X EP System Wave Speed Map Software License
ST. JUDE MEDICAL, INC.
ENSITE-WS-01
In Commercial Distribution

  • 05415067038111 ()
ENSITE-WS-01

  • Cardiac mapping system application software
Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-WS-01
In Commercial Distribution

  • 05415067038098 ()
ENSITE-D-WS-01

  • Cardiac mapping system application software
X EP System Omnipolar Technology Data Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTEXPORT-01
In Commercial Distribution

  • 05415067037770 ()
ENSITE-OTEXPORT-01

  • Cardiac mapping system application software
Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1
In Commercial Distribution

  • 05415067037763 ()
ENSITE-SW-1.1

  • Cardiac mapping system application software
X EP System LiveView Dynamic Display Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LV-01
In Commercial Distribution

  • 05415067037749 ()
ENSITE-D-LV-01

  • Cardiac mapping system application software
X EP System Live Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-LE-01
In Commercial Distribution

  • 05415067037732 ()
ENSITE-LE-01

  • Cardiac mapping system application software
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