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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ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000725NS
In Commercial Distribution

  • 50749756874330 ()
  • 00749756874335 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000722NS
In Commercial Distribution

  • 50749756872589 ()
  • 00749756872584 ()


  • Surgical plume evacuation system
VisiClear Surgical Smoke Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
VC220P1
Not in Commercial Distribution

  • 20845854081355 ()
VC220P1

  • Surgical plume evacuation system
VisiClear Surgical Smoke Evacuator 220V-240V 50/60Hz
Conmed Corporation
VC220NF
Not in Commercial Distribution

  • 20845854081348 ()
VC220NF

  • Surgical plume evacuation system
VisiClear Surgical Smoke Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
VC220
In Commercial Distribution

  • 20845854081324 ()
VC220

  • Surgical plume evacuation system
ViroVac Surgical Smoke Evacuator With Filter 220V-240V 50/60 Hz
Conmed Corporation
VV220
In Commercial Distribution

  • 20845854081317 ()
VV220

  • Surgical plume evacuation system
PlumeSafe TURBO Surgical Smoke Evacuator 220V-240V 50/60 Hz
Conmed Corporation
PSWTURBO_AS/220
In Commercial Distribution

  • 20845854081195 ()
PSWTURBO_AS 220

  • Surgical plume evacuation system
MiniVac Smoke Evacuation System 220-240V 50/60 Hz
Conmed Corporation
ECVV220
Not in Commercial Distribution

  • 20845854053109 ()
ECVV220

  • Surgical plume evacuation system
MiniVac Smoke Evacuation System 100V-120V 50/60 Hz
Conmed Corporation
ECVV120
Not in Commercial Distribution

  • 20845854053093 ()
ECVV120

  • Surgical plume evacuation system
AER DEFENSE SMOKE EVACUATOR SYSTEM
Conmed Corporation
60-8080-230
In Commercial Distribution

  • 20653405059094 ()
  • 10653405059097 ()
60-8080-230

  • Surgical plume evacuation system
AER DEFENSE SMOKE EVACUATOR SYSTEM
Conmed Corporation
60-8080-120
In Commercial Distribution

  • 20653405059087 ()
  • 10653405059080 ()
60-8080-120

  • Surgical plume evacuation system
MEGADYNE TES RF Sensor Cable
MEGADYNE MEDICAL PRODUCTS, INC.
2255JTES
In Commercial Distribution

  • 10705036046523 ()
  • 20705036046520 ()
2255JTES

  • Surgical plume evacuation system
Universial Smoke Evac Attachment
DEROYAL INDUSTRIES, INC.
88-3590NS
In Commercial Distribution

  • 50749756231256 ()
  • 00749756231251 ()


  • Surgical plume evacuation system
No Description
NORTHGATE TECHNOLOGIES INC.
7-700-00
In Commercial Distribution

  • 00817183020684 ()


  • Surgical plume evacuation system
ICM-000-0644 STERIS Laser Sensor
I.C. MEDICAL, INC.
SSESEN02
Not in Commercial Distribution

  • 00817688023517 ()
SSESEN02

  • Surgical plume evacuation system
ICM-000-0645 STERIS Foot Switch
I.C. MEDICAL, INC.
SSESEN03
Not in Commercial Distribution

  • 00817688023524 ()
SSESEN03

  • Surgical plume evacuation system
ICM-000-0643 STERIS RF Sensor, Shielded
I.C. MEDICAL, INC.
SSESEN01
Not in Commercial Distribution

  • 00817688023500 ()
SSESEN01

  • Surgical plume evacuation system
ICM-000-0606 STERIS Large Coconut Charcoal Output Filter, Non-Sterile
I.C. MEDICAL, INC.
SSEFIL02
Not in Commercial Distribution

  • 00817688023012 ()
SSEFIL02

  • Surgical plume evacuation system
ICM-000-0604 STERIS Hydrophobic ULPA Filter with Built-in Fluid Trap, Non-Sterile
I.C. MEDICAL, INC.
SSEFIL01
Not in Commercial Distribution

  • 00817688023005 ()
  • 00817688022992 ()
SSEFIL01

  • Surgical plume evacuation system
ICM-460-0001 STERIS Smoke Evacuation System
I.C. MEDICAL, INC.
SSECAPREG
Not in Commercial Distribution

  • 00817688022985 ()
SSECAPREG

  • Surgical plume evacuation system
ICM-450-0001 STERIS Smoke Evacuation System Plus
I.C. MEDICAL, INC.
SSECAPPLS
Not in Commercial Distribution

  • 00817688022978 ()
SSECAPPLS

  • Surgical plume evacuation system
No Description
Brainlab AG
2.3.1
Not in Commercial Distribution

  • 04056481132453 ()
25100-12A

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
2.3
Not in Commercial Distribution

  • 04056481006662 ()
25100-12

  • Radiology picture archiving and communication system workstation
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11669400
In Commercial Distribution

  • 04068151012477 ()


  • General-purpose ultrasound imaging system
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160206 ()


  • Glucose monitoring system IVD, home-use
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160145 ()


  • Glucose monitoring system IVD, home-use
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160077 ()


  • Glucose monitoring system IVD, home-use
Prime Calibrator Cartridge CCS Comp 300 Sample
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480524278 ()
52427

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
  • Assisted reproduction centrifuge tube
In vitro diagnostic reagent for the quantitative determination of alpha2macroglobulin in samples of human origin (serum, heparinized plasma) by immunoturbidimetry on the cobas c systems.
Diagam
09029524190
In Commercial Distribution

  • 05415168006873 ()
09029524190

  • Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry
AURORA NM GANTRY FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
SPECT with Revolution Ascend CT
In Commercial Distribution

  • 00195278878502 ()


  • Full-body CT system
  • Stationary gamma camera system
StarGuide SW and Labels Upgrade
G E MEDICAL SYSTEMS ISRAEL LTD.
5962426
In Commercial Distribution

  • 00195278870490 ()
5962426

  • Stationary gamma camera system
  • Full-body CT system
D630 to D670 DR NM GANTRY UPGRADE KIT
G E MEDICAL SYSTEMS ISRAEL LTD.
H3101RS
In Commercial Distribution

  • 00195278794772 ()
5953035

  • Stationary gamma camera system
  • Full-body CT system
870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
870 DR
In Commercial Distribution

  • 00195278788269 ()


  • Stationary gamma camera system
  • Full-body CT system
StarGuide NM GANTRY MDR FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
H3911BJ
In Commercial Distribution

  • 00195278755544 ()
5842898-10

  • Stationary gamma camera system
  • Full-body CT system
STARGATE NM GANTRY FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
H3911AB
In Commercial Distribution

  • 00195278118295 ()


  • Stationary gamma camera system
  • Full-body CT system
D630 to D670 DR NM GANTRY UPGRADE KIT
GE Hualun Medical Systems Co., Ltd
H2401DS
In Commercial Distribution

  • 00840682154338 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906ER
In Commercial Distribution

  • 00840682146401 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906EF
In Commercial Distribution

  • 00840682145947 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3908AX
In Commercial Distribution

  • 00840682145930 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906DX
In Commercial Distribution

  • 00840682145725 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3907AN
In Commercial Distribution

  • 00840682145527 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3907AR
In Commercial Distribution

  • 00840682145510 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3908AP
In Commercial Distribution

  • 00840682145497 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H308AK
In Commercial Distribution

  • 00840682145480 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3908AM
In Commercial Distribution

  • 00840682145473 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906DT
In Commercial Distribution

  • 00840682145459 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3907AT
In Commercial Distribution

  • 00840682145442 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906DE
In Commercial Distribution

  • 00840682141635 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
870CZT
In Commercial Distribution

  • 00840682140843 ()


  • Full-body CT system
  • Stationary gamma camera system
870 DR NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
870 DR
In Commercial Distribution

  • 00840682140836 ()


  • Stationary gamma camera system
  • Full-body CT system
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