Company Name Brand Name GMDN Term 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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RC MCCOY SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-54-0102-24
In Commercial Distribution

  • 30014613335801 ()
F-54-0102-24

  • Cell culture line IVD
Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical
The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical
Smoke Evacuator 110V
Covidien LP
SE3690ZD
In Commercial Distribution

  • 10884521134140 ()
SE3690ZD

  • Surgical plume evacuation system
Smoke Evacuator,220-240 V, 50/60 Hz; 8 Amps
Covidien LP
SE3695
In Commercial Distribution

  • 10884524001753 ()
SE3695

  • Surgical plume evacuation system
Smoke Evacuator,100-120 V, 50/60 Hz; 10 Amps
Covidien LP
SE3690
In Commercial Distribution

  • 10884524001555 ()
SE3690

  • Surgical plume evacuation system
Compactor
SpineArt SA
PAD-IN 05 00-N
In Commercial Distribution

  • 07640139349309 ()
PAD-IN 05 00-N

  • Bone graft packing block
Compaction Base
SpineArt SA
PAD-IN 04 00-N
In Commercial Distribution

  • 07640139349293 ()
PAD-IN 04 00-N

  • Bone graft packing block
No Description
I.C. MEDICAL, INC.
ICM-000-0561
In Commercial Distribution

  • 00817688022411 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0546
In Commercial Distribution

  • 00817688021759 ()


  • Surgical plume evacuation system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003033 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003002 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
QUIKLINK Automatic Activation Device for SMOKE-E-VAC Smoke Plume Evacuator
Conmed Corporation
QUIKLINK
In Commercial Distribution

  • 30845854061231 ()
QUIKLINK

  • Surgical plume evacuation system
No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Tecapro mt.
Innovasis, Inc.
LS-215
In Commercial Distribution

  • M711LS2150 ()
LS-215

  • Bone graft packing block
ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
AZIYO BIOLOGICS, INC.
CMCV-060-402
In Commercial Distribution

  • 10859389005017 ()
  • 00859389005010 ()

  • Width: 7.0 Centimeter
  • Height: 15.0 Centimeter


  • Cardiovascular patch, animal-derived
ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
AZIYO BIOLOGICS, INC.
CMCV-059-401
In Commercial Distribution

  • 00859389005003 ()
  • 10859389005000 ()

  • Height: 10 Centimeter
  • Width: 7 Centimeter


  • Cardiovascular patch, animal-derived
ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
AZIYO BIOLOGICS, INC.
CMCV-067-404
In Commercial Distribution

  • 10859389005055 ()
  • 00859389005058 ()

  • Width: 7 Centimeter
  • Height: 4 Centimeter


  • Cardiovascular patch, animal-derived
ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
AZIYO BIOLOGICS, INC.
CMCV-064-401
In Commercial Distribution

  • 10859389005048 ()
  • 00859389005041 ()

  • Width: 7 Centimeter
  • Height: 10 Centimeter


  • Cardiovascular patch, animal-derived
Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • Implantable intrathecal infusion pump, programmable
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