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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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Activator - 08625630003010

Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump

Activator - 08625630003001

Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump

Activator Kit - 00862563003184

Magnetic remote control for the inFlow Device - with base station and medical charger
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003184 ()
403507K

  • Intraurethral valve/pump

Alpha2-macroglobulin - 05415168006873

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

Atalante X - 03665965000129

The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
WANDERCRAFT
ATA-002-EN US
In Commercial Distribution

  • 03665965000129 ()


  • Programmable ambulation exoskeleton, clinical

Base Station - 00862563003160

Unit for storing and recharging the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003160 ()
403310

  • Intraurethral valve/pump

BioRef-DC - 07290017249049

BIOFEEDBACK DEVICE BioRef-DC
TAVGER LTD
FG00019
In Commercial Distribution

  • 07290017249049 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

BodyMD - 05711665003019

Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003019 ()

  • Width: 291 Centimeter
  • Depth: 197 Centimeter
  • Height: 225 Centimeter
  • Weight: 2144 Kilogram
9PMS3131

  • Stationary gamma camera system

BodyMD - 05711665003026

Gamma Camera System
Ddd-Diagnostic A/S
BodyMD Gamma Camera System
Not in Commercial Distribution

  • 05711665003026 ()

  • Width: 291 Centimeter
  • Depth: 197 Centimeter
  • Height: 225 Centimeter
  • Weight: 2144 Kilogram
9PMS3131

  • Stationary gamma camera system

Bovie - 10607151008496

BOVIE EZ LINK
BOVIE MEDICAL CORPORATION
SERS2
In Commercial Distribution

  • 10607151008496 ()
SERS2

  • Surgical plume evacuation system

Bovie - 10607151008304

SMOKE SHARK II 120V-220V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02-220
In Commercial Distribution

  • 10607151008304 ()
SE02-220

  • Surgical plume evacuation system

Bovie - 10607151008298

SMOKE SHARK II 120 V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02
In Commercial Distribution

  • 10607151008298 ()
SE02

  • Surgical plume evacuation system

Bovie - 10607151004801

PNEUMATIC FOOTSWITCH - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
FSSEP
In Commercial Distribution

  • 10607151004801 ()
FSSEP

  • Surgical plume evacuation system

Brivo - 00840682139267

No Description
Hangwei GE Medical Systems Co., Ltd.
NM 615
In Commercial Distribution

  • 00840682139267 ()


  • Stationary gamma camera system

Brivo 615 - 00840682117869

No Description
Hangwei GE Medical Systems Co., Ltd.
5376496-15
In Commercial Distribution

  • 00840682117869 ()


  • Stationary gamma camera system

C.Cam - 05711665001008

Gamma Camera System
Ddd-Diagnostic A/S
c.cam Gamma Camera System
In Commercial Distribution

  • 05711665001008 ()

  • Weight: 1350 Kilogram
  • Height: 169 Centimeter
  • Depth: 229 Centimeter
  • Width: 244 Centimeter
9VIR1200

  • Stationary gamma camera system

CLEARVIEW - 30845854081178

ClearView Smoke Evacuation Unit with ClearView Smoke Evacuator Filter 220V-240V 50/60Hz
Conmed Corporation
60-8585-230
In Commercial Distribution

60-8585-230

  • Surgical plume evacuation system

CLEARVIEW - 30845854081208

ClearView Smoke Evacuation Unit with ClearView Smoke Evacuator Filter 100V-120V 50/60Hz
Conmed Corporation
60-8585-120
In Commercial Distribution

60-8585-120

  • Surgical plume evacuation system

CYNOSURE - 30845854081116

CYNOSURE VIROVAC 220V SMOKE EVACUATOR/FILTER/NON-STERILE TUBING
Conmed Corporation
CYNOSUREVV220K
In Commercial Distribution

  • 30845854081116 ()
CYNOSUREVV220K

  • Surgical plume evacuation system

CZT Upgrade - 00840682141635

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906DE
In Commercial Distribution

  • 00840682141635 ()


  • Full-body CT system
  • Stationary gamma camera system
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