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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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Advance Biometrix - B353AB12571

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

  • B353AB12572 ()
  • B353AB12571 ()
  • B353AB12573 ()
AB1257_US

  • Electrocardiographic ambulatory recorder

DEXcam4™ Intra-oral camera - EKAV101149960

Digital intraoral camera
DEXIS LLC
1.011.4996
In Commercial Distribution

  • EKAV101149960 ()
PLU7610K

  • Multi-purpose digital medical camera

Gendex GXC-300™ intraoral camera - EKAV100719700

Digital intraoral cameraDigital intraoral camera
GENDEX CORP.
1.007.1970
In Commercial Distribution

  • EKAV100719700 ()
120 0209G1

  • Multi-purpose digital medical camera

DEXcam3™ intraoral cameras - EKAV100719690

Digital intraoral camera
DEXIS LLC
1.007.1969
In Commercial Distribution

  • EKAV100719690 ()
PLU791

  • Multi-purpose digital medical camera

DEXcam3™ intraoral cameras - EKAV100713330

Digital intraoral camera
DEXIS LLC
1.007.1333
In Commercial Distribution

  • EKAV100713330 ()
PLU790

  • Multi-purpose digital medical camera

Gendex GXC-300™ intraoral camera - EKAV082243310

Digital intraoral camera
GENDEX CORP.
0.822.4331
In Commercial Distribution

  • EKAV082243310 ()
GXC300

  • Multi-purpose digital medical camera

DEXcam3™ intraoral cameras - EKAV101289070

Digital intraoral camera
DEXIS LLC
1.012.8907
In Commercial Distribution

  • EKAV101289070 ()
1.012.8907

  • Multi-purpose digital medical camera

DEXcam3™ intraoral cameras - EKAV101289030

Digital intraoral camera
DEXIS LLC
1.012.8903
In Commercial Distribution

  • EKAV101289030 ()
1.012.8903

  • Multi-purpose digital medical camera

DEXcam4™ Intra-oral camera - EKAV101149840

No Description
DEXIS LLC
1.011.4984
In Commercial Distribution

  • EKAV101149840 ()
PLU760

  • Multi-purpose digital medical camera

Saver EVO - M727SAVEREVOH013

Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution

  • M727SAVEREVOH013 ()
PAD-ACC-03

  • External defibrillator application software
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