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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No Description
WestGroupe Optical Inc
F-3682 TEAL JAPAN GOLD
In Commercial Distribution

  • 00676190612677 ()


  • Spectacle frame
The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision® Treatment Planning System and iDMS™ Data Management System.
Accuray Incorporated
032500-M-000
In Commercial Distribution

NA

  • Linear accelerator system
Defibrillator ,MAIN,ALS,MAN-1,3/5 LD,STD ECG,AC PWR,SPO2,ETCO2,PACE,NIBP,CF/USB,R SERIES, JAPAN
Zoll Medical Corporation
30001005201310362
In Commercial Distribution

  • 04560233593121 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NIBP, NIBP-MOD-G, SPO2, CPR EXPANSION PACK AND ETCO2, JAPAN
Zoll Medical Corporation
610-0121001-36
In Commercial Distribution

  • 04560233592995 ()

  • 8.9" x 10.4" x 8.75"


  • Rechargeable professional automated external defibrillator
POWER PROSTHETIC KIT 1.2mm: Ankylos,Neobiotech, Dio, Hiossen/Ostem, Megagen.1.25mm: Astra, Dentium, Zimmer.1.3mm: Japan .etc.B/M: Branemark. Nobel Biocare.S/M: Straumann.
Power Dental U.S.A. Inc.
N7813N
In Commercial Distribution

  • D943N7813N00 ()
N7813N

  • Intraoperative orthopaedic bone pin/screw, single-use
Kit includes: PC-ECG 1200W (UDI: 07290110252076) wireless Stress-Test Kit; Input cable with ten leads AHA type and Snap connectors. Special edition for TAISHO, Japan
NORAV MEDICAL LTD.
1200W Kit
In Commercial Distribution

  • 07290110255190 ()
1200W2-K-00-U-S10-20

  • Electrocardiography telemetric monitoring system transmitter
POWER PROSTHETIC KIT ..1.2mm: Ankylos,Neobiotech, Dio, Hiossen/Ostem, Megagen...1.25mm: Astra, Dentium, Zimmer...1.3mm: Japan .etc...B/M: Branemark. Nobel Biocare...S/M: Straumann.
Power Dental U.S.A. Inc.
7813
In Commercial Distribution

  • D9437813 ()
7813

  • Dressing/utility forceps, scissors-like, reusable
  • Intraoperative orthopaedic bone pin/screw, single-use
HDi System Overpack, with ACIST Connect, JAPAN p/n 801081-001 Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply, ACI Hardware
ACIST MEDICAL SYSTEMS, INC.
016323
Not in Commercial Distribution

  • 40841716102057 ()


  • Cardiovascular ultrasound imaging system
No Description
Terumo Cardiovascular Systems Corporation
CV-6914
In Commercial Distribution

  • 50699753270133 ()
  • 30699753270139 ()
  • 00699753270138 ()


  • Cardiopulmonary bypass system blood gas sensor
No Description
Terumo Cardiovascular Systems Corporation
CV-6913
In Commercial Distribution

  • 50699753270126 ()
  • 30699753270122 ()
  • 00699753270121 ()


  • Cardiopulmonary bypass system blood gas sensor
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