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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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TRICYCLICS LEVEL 2 V2 - B800TCAL2V2SMAYO0

TRICYCLICS LEVEL 2 V2
UTAK LABORATORIES, INC.
TCA L2 V2 S MAYO
In Commercial Distribution

  • B800TCAL2V2SMAYO5 ()
  • B800TCAL2V2SMAYO0 ()

  • Total Volume: 1 Milliliter
TCA L2 V2 S MAYO

  • Multiple antidepressant therapeutic drug monitoring IVD, control

aycan xray-print - 04260476510045

No Description
aycan Digitalsysteme GmbH
v2
In Commercial Distribution

  • 04260476510045 ()


  • Radiology picture archiving and communication system workstation

TASK FORCE® MONITOR 3030i SET - 09120073930705

Type 3030i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930675, Flying-V - finger cuff (large) 09120073930682, Flying-V - finger cuff (medium) 09120073930699, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102182, 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930705 ()
03038

  • Noninvasive haemodynamic monitoring system

TASK FORCE® MONITOR 3040i - 09120073932150

Main Unit;
CNSystems Medizintechnik GmbH
V2
In Commercial Distribution

  • 09120073932150 ()
FHTF3049

  • General-purpose multi-parameter bedside monitor

TASK FORCE® MONITOR 3040i - 09120073931924

Main Unit;
CNSystems Medizintechnik GmbH
V2
Not in Commercial Distribution

  • 09120073931924 ()
FHTF3141

  • General-purpose multi-parameter bedside monitor

TASK FORCE® MONITOR 3030i SET - 09120073930804

Type 3030i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930538, Flying-V - finger cuff (large) 09120073930545, Flying-V - finger cuff (medium) 09120073930552, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102182, 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930804 ()
03038

  • Noninvasive haemodynamic monitoring system

TASK FORCE® MONITOR 3040i SET - 09120073930712

Type 3040i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930507, ICG cable, 2.5m, ICG cable with protection against defibrillation, "double nose" connector 09120073930460; 20pcs., Set of electrodes; Set include 4ECG electrodes, 3 ICG electrodes and one grounding pad 09120073930675, Flying-V - finger cuff (large) 09120073930682, Flying-V - finger cuff (medium) 09120073930699, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 10840935102182, Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930712 ()
03141

  • Noninvasive haemodynamic monitoring system

TASK FORCE® MONITOR 3040i - 09120073930644

Main Unit;
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930644 ()
00361

  • Noninvasive haemodynamic monitoring system

TASK FORCE® MONITOR 3040i SET - 09120073930637

Type 3040i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930507, ICG cable, 2.5m, ICG cable with protection against defibrillation, "double nose" connector 09120073930460; 20pcs., Set of electrodes; Set include 4ECG electrodes, 3 ICG electrodes and one grounding pad 09120073930538, Flying-V - finger cuff (large) 09120073930545, Flying-V - finger cuff (medium) 09120073930552, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 10840935102182, Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930637 ()
03141

  • Noninvasive haemodynamic monitoring system

myPKFiT for Patients Mobile Application - 00850025688826

Mobile application used by patients for disease management
Takeda Pharmaceuticals U.S.A., Inc.
V2
In Commercial Distribution

  • 00850025688826 ()


  • Home pharmaceutical management support software

PeekMed - 05600120304801

PeekMed is a system that allows healthcare professionals to plan a surgery procedure simulating various environments, from hybrid (2D/3D) to 3D or 2D environments. In the case of a 3D or hybrid environment, the healthcare professional can resort to a 3D model generated from a previous imaging study on the patient and 3D digital representations of the implant material to be used during surgery, i.e. screws, fixation plates, or full prosthesis, deriving from several producing companies. Being software it does not interact with any part of the body of the user and/or patient.
PEEK HEALTH, S.A.
v2
In Commercial Distribution

  • 05600120304801 ()


  • Orthopaedic/craniofacial implantation planning software

Persyst ESI powered by Epilog - 05430000733045

Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report. Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software

PreOp - 05430000733021

PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software

MAXIO - 08908002051063

MAXIO V2 is a stereotactic accessory intended for the spatial positioning and orientation of an instrument guide to assist in manual advancement of one or more instruments for image guided procedures. It provides Preoperative planning and intra operative guidance to the surgeon by visually representing the targeted path and position(s) on the image based model of the target organ along with the data provided by the instrument manufacturer.
PERFINT HEALTHCARE PRIVATE LIMITED
V2
In Commercial Distribution

  • 08908002051063 ()


  • Robotic surgical navigation system

munevo DRIVE - 04260691380010

No Description
Munevo Inc.
V2
In Commercial Distribution

  • 04260691380010 ()


  • Wheelchair steering/control unit

DTE - 06944843600123

Ultrasonic Scalers
Guilin Woodpecker Medical Instrument Co., Ltd.
V2
In Commercial Distribution

  • 06944843600123 ()


  • Ultrasonic dental scaling/debridement system

DTE - 06944843600062

Dental Ultrasonic Scaler
Guilin Woodpecker Medical Instrument Co., Ltd.
V2
In Commercial Distribution

  • 06944843600062 ()


  • Ultrasonic dental scaling/debridement system

Bondent - 06942135219558

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219554 ()
  • 06942135219558 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219541

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219547 ()
  • 06942135219541 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219534

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219530 ()
  • 06942135219534 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219527

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219523 ()
  • 06942135219527 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219510

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219516 ()
  • 06942135219510 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219503

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219509 ()
  • 06942135219503 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219497

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219493 ()
  • 06942135219497 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219480

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219486 ()
  • 06942135219480 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219473

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219479 ()
  • 06942135219473 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219466

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219462 ()
  • 06942135219466 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219459

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219455 ()
  • 06942135219459 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219442

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219448 ()
  • 06942135219442 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Bondent - 06942135219435

No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219431 ()
  • 06942135219435 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
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