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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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Microlife - 06970388169504

No Description
MICROLIFE USA, INC.
Cuff-M-WBPA
In Commercial Distribution

  • 16970388169501 ()
  • 06970388169504 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 06970388169498

No Description
MICROLIFE USA, INC.
CUFF-S-WBPA
In Commercial Distribution

  • 16970388169495 ()
  • 06970388169498 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 06970388169467

No Description
MICROLIFE USA, INC.
CUFF-LXL-WBPO
In Commercial Distribution

  • 16970388169464 ()
  • 06970388169467 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169450

No Description
MICROLIFE USA, INC.
Cuff-L-WBPO
In Commercial Distribution

  • 16970388169457 ()
  • 06970388169450 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169443

No Description
MICROLIFE USA, INC.
Cuff-M-WBPO
In Commercial Distribution

  • 16970388169440 ()
  • 06970388169443 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169436

No Description
MICROLIFE USA, INC.
CUFF-S-WBPO
In Commercial Distribution

  • 16970388169433 ()
  • 06970388169436 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169429

No Description
MICROLIFE USA, INC.
Cuff-L-WBPH
In Commercial Distribution

  • 16970388169426 ()
  • 06970388169429 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169290

No Description
MICROLIFE USA, INC.
Cuff-S-WBPH
In Commercial Distribution

  • 16970388169297 ()
  • 06970388169290 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169221

No Description
MICROLIFE USA, INC.
Cuff-LXL-WBPH
In Commercial Distribution

  • 16970388169228 ()
  • 06970388169221 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169191

No Description
MICROLIFE USA, INC.
CUFF-M-WBPH
In Commercial Distribution

  • 16970388169198 ()
  • 06970388169191 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 06970388169160

No Description
MICROLIFE USA, INC.
BP3MX1-3
In Commercial Distribution

  • 16970388169167 ()
  • 06970388169160 ()
  • 26970388169164 ()


  • Arrythmia-detection sphygmomanometer

Pdt-Face - 06970453270005

No Description
Beijing ADSS Development Co., Ltd.
PDT-FACE
In Commercial Distribution

  • 06970453270005 ()


  • Red/blue light phototherapy unit

MiVu - 00816734022481

MiVu Balloon
DIVERSATEK HEALTHCARE, INC.
MI-BAL-01
In Commercial Distribution

  • 00816734022481 ()

  • Balloon Diameter: 20 Millimeter
MI-BAL-01

  • Manometric gastrointestinal motility analysis system

Archimedes Planning System - 00856571007104

Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue.
BRONCUS MEDICAL INC.
40009
In Commercial Distribution

  • 00856571007104 ()
40009

  • Virtual bronchoscopic navigation PACS software

Bittium Faros 180 waterproof - 06430035220328

Device for 1-channel ECG and motion measurement, monitoring and data collection
Bittium Biosignals Oy
Faros 180
In Commercial Distribution

  • 06430035220328 ()


  • Telemetric electrocardiographic ambulatory recorder

Bittium Faros - 06430035220366

Device for 3-channel ECG and motion measurement, monitoring and data collection
Bittium Biosignals Oy
Faros 14d
In Commercial Distribution

  • 06430035220366 ()


  • Telemetric electrocardiographic ambulatory recorder

Faros 360 waterproof - 06430035220311

Device for 3-channel ECG and motion measurement, monitoring and data collection.
Bittium Biosignals Oy
Faros 360
In Commercial Distribution

  • 06430035220311 ()
901159

  • Telemetric electrocardiographic ambulatory recorder

Volk Pictor Prestige retinal set - 06430046260887

Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Prestige retina module.
Optomed Oy
60101813A
In Commercial Distribution

  • 06430046260887 ()


  • Multi-purpose digital medical camera

Volk Pictor Prestige full set - 06430046260870

Volk Pictor Prestige full set including Pictor Prestige camera, Pictor Prestige Retina module and Pictor Prestige Anterior module.
Optomed Oy
60101810A
In Commercial Distribution

  • 06430046260870 ()


  • Multi-purpose digital medical camera

Optomed Aurora retinal set - 06430046260795

Optomed Aurora retinal set including Aurora camera and Aurora retinal module.
Optomed Oy
60101078A
In Commercial Distribution

  • 06430046260795 ()


  • Multi-purpose digital medical camera

Optomed Aurora full set - 06430046260757

Aurora full set including Aurora camera, Aurora Retinal module and Aurora Anterior module.
Optomed Oy
60100635A
In Commercial Distribution

  • 06430046260757 ()


  • Multi-purpose digital medical camera

Pictor M5WEY4 Volk FN - 06430046260672

Volk Pictor Plus retinal set
Optomed Oy
60100077A
In Commercial Distribution

  • 06430046260672 ()


  • Multi-purpose digital medical camera

Pictor M5WEY4ES2 Volk FN - 06430046260658

Volk Pictor Plus full set
Optomed Oy
60100075A
In Commercial Distribution

  • 06430046260658 ()


  • Multi-purpose digital medical camera

CORE12 - 00853512007001

Multi Function Device
APPLIED CARDIAC SYSTEMS, INC.
C18006
In Commercial Distribution

  • 00853512007001 ()


  • Telemetric electrocardiographic ambulatory recorder

Ceiba - 00860006137014

Brand-independent integration with Ceiba eConnect APIs of medical devices (monitors, respirators, pumps, blood gas) and hospital systems
Ceiba Healthcare Technologies LLC
ECONNECT IoMT Box
In Commercial Distribution

  • 00860006137014 ()


  • Medical networking interface unit

Lumicell Direct Visualization System (DVS) - 00860003252543

Workstation Assembly
Lumicell, Inc.
810-00217
In Commercial Distribution

  • 00860003252543 ()
  • 00860008537805 ()


  • Intraoperative tumour margin fluorescence imaging system

Lumicell Direct Visualization System (DVS) - 00860003252536

Light source
Lumicell, Inc.
810-00212
In Commercial Distribution

  • 00860003252598 ()
  • 00860003252536 ()


  • Intraoperative tumour margin fluorescence imaging system

Canary Clinic Base Station - 00860003118368

No Description
Canary Medical USA LLC
43-5570-005-14
In Commercial Distribution

  • 00860003118368 ()


  • Medical networking interface unit

Canary Home Base Station - 00860003118320

The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Canary Medical USA LLC
43-5570-001-14
In Commercial Distribution

  • 00860003118320 ()


  • Medical networking interface unit

Canary OR Base Station / OR PC App / OR Registration - 00860003118313

The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution

  • 00860003118313 ()


  • Medical networking interface unit
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