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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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EnSite™ - 05414734210881

RecordConnect Module Recording System Connector
ST. JUDE MEDICAL, INC.
H421088
In Commercial Distribution

  • 05414734210881 ()
H421088

  • Electrical-only medical device connection cable, reusable
  • Cardiac mapping system

EchoGo - 05060634690010

No Description
ULTROMICS LIMITED
Pro
In Commercial Distribution

  • 05060634690010 ()


  • Ultrasound imaging system application software
  • Cardiac mapping system application software

Pathway - 00852423006011

Pathway® CTS 2000
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS2000
In Commercial Distribution

  • 00852423006011 ()
CTS2000

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional

Pathway - 00852423006028

Pathway® CTS 1500
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS1500
In Commercial Distribution

  • 00852423006028 ()
CTS1500

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional

WVSM Wireless Vital Signs Monitor - B3945000001120

Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution

  • B3945000001120 ()
500-0001-12

  • Multiple vital physiological parameter monitoring system, clinical
  • Multiple-patient intensive/general healthcare physiologic monitoring system

WVSM Wireless Vital Signs Monitor - B3945000001010

Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution

  • B3945000001010 ()
500-0001-01

  • Multiple-patient intensive/general healthcare physiologic monitoring system
  • Multiple vital physiological parameter monitoring system, clinical

EVA SELECT DIRECT - D83399924132050

EVA SELECT DIRECT SIZE 2 SENSOR ONLY
ImageWorks
9992413205
In Commercial Distribution

  • D83399924132050 ()
9992413205

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT DIRECT - D83399924132000

EVA SELECT DIRECT SIZE 2 SYSTEM
ImageWorks
9992413200
In Commercial Distribution

  • D83399924132000 ()
9992413200

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT DIRECT - D83399924131050

EVA SELECT DIRECT SIZE 1 SENSOR ONLY
ImageWorks
9992413105
In Commercial Distribution

  • D83399924131050 ()
9992413105

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT DIRECT - D83399924131000

EVA SELECT DIRECT SIZE 1 SYSTEM
ImageWorks
9992413100
In Commercial Distribution

  • D83399924131000 ()
9992413100

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral
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