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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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No Description
NOVODIAX, INC.
C30005-005ML
In Commercial Distribution

  • 00850030934932 ()

  • Total Volume: 5 Milliliter


  • Immunohistochemistry conjugated secondary antibody IVD
No Description
HYCOR BIOMEDICAL LLC
W43
Not in Commercial Distribution

  • 00816879025675 ()
745040

  • Assay development analyte-specific reagent IVD
No Description
HYCOR BIOMEDICAL LLC
63140
Not in Commercial Distribution

  • 00816879023008 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
G007
Not in Commercial Distribution

  • 00816879022001 ()
74982

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
No Description
UTAK LABORATORIES, INC.
BENZU CP QC 2 V3
In Commercial Distribution

  • B800BENZUCPQC2V35 ()
  • B800BENZUCPQC2V30 ()

  • Total Volume: 1.2 Milliliter
BENZU CP QC 2 V3

  • Multiple-type clinical chemistry analyte profile IVD, control
The CardioGraphe is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.
ARINETA LTD
Spotlight
In Commercial Distribution

  • 07290016484007 ()

  • Gantry; Source to detector distance 854 mm
  • Gantry; Source to isocenter distance 450 mm
  • Focused Field of View 250 mm
  • Table; Horizontal range 150 cm
  • Table; Vertical range 45/50 cm to 82.5/87.5 cm


  • Full-body CT system
The Access Thyroglobulin Sample Diluent is intended for use with the Access Thyroglobulin Assay to dilute patient samples containing thyroglobulin (Tg) concentrations greater than the S5 calibrator.
Beckman Coulter, Inc.
33866
In Commercial Distribution

  • 15099590225858 ()
33866

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
To prepare physicians and dental practices with advanced cardiac life support medications to respond to medical emergencies until EMS arrives.
HF ACQUISITION CO. LLC
1003471
Not in Commercial Distribution

  • 00850065007342 ()
1003471

  • First aid kit, medicated
An x-ray system component intended to be mounted to the floor, to support and facilitate position of the x-ray tube.
Del Medical, Inc.
FMT
In Commercial Distribution

  • 00858340006318 ()


  • X-ray system tube support, floor standing
The Reliance Endoscope Transport cart is designed to safely and easily transport endoscopes to a procedure room or to reprocessing.
Corporation Steris Canada
RETCART01
Not in Commercial Distribution

  • 00724995197711 ()
RETCART01

  • Surgical/procedural instrument transport cabinet
The device is intended to be used to clamp surgical instruments to the adult thoracic retractors manufactured by CORONEO INC.
Coroneo Inc
1100347
In Commercial Distribution

  • 10817121000287 ()
1100347

  • Surgical instrument assist arm system structural component
Bone molder - used to compress bone in between dental Implants at time of placement - Offset to allow access to posterior
Suncoast Dental, Inc
Bone Molder - Offset
In Commercial Distribution

  • 00083208130137 ()
Bone Molder - Offset

  • Osteotomy compression/distraction instrument
Used to carry the implant from the package to the surgical site and to drive the implant into the bone.
STERNGOLD DENTAL LLC
905286
In Commercial Distribution

  • 00841549118098 ()


  • Surgical screwdriver, reusable
Used to carry the implant from the package to the surgical site and to drive the implant into the bone.
STERNGOLD DENTAL LLC
905285
In Commercial Distribution

  • 00841549118081 ()


  • Surgical screwdriver, reusable
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
19 FLEXIBLE channels
In Commercial Distribution

  • EBCI5730PRO0 ()
5730PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16 FLEXIBLE channels
In Commercial Distribution

  • EBCI5710PRO0 ()
5710PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
8-Channel
In Commercial Distribution

  • EBCI5120PRO0 ()

  • Channel Number 8
5120PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel-rX
In Commercial Distribution

  • EBCI5112PRO0 ()

  • Channel Number 16
5112PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel-mB
In Commercial Distribution

  • EBCI5111PRO0 ()

  • Channel Number 16
5111PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel
In Commercial Distribution

  • EBCI5110PRO0 ()

  • Channel Number 16
5110PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel-CSP
In Commercial Distribution

  • EBCI5101PRO0 ()

  • Channel Number 32
5101PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
8 FLEXIBLE channels
In Commercial Distribution

  • EBCI5720PRO0 ()
5720PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32 FLEXIBLE channels
In Commercial Distribution

  • EBCI5700PRO0 ()
5700PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
8-Channel Sahara
In Commercial Distribution

  • EBCI5220PRO0 ()

  • Channel Number 8
5220PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel-rX Sahara
In Commercial Distribution

  • EBCI5212PRO0 ()

  • Channel Number 16
5212PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel-mB Sahara
In Commercial Distribution

  • EBCI5211PRO0 ()

  • Channel Number 16
5211PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel Sahara
In Commercial Distribution

  • EBCI5210PRO0 ()

  • Channel Number 16
5210PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel-CSP Sahara
In Commercial Distribution

  • EBCI5201PRO0 ()

  • Channel Number 32
5201PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel Sahara
In Commercial Distribution

  • EBCI5200PRO0 ()

  • Channel Number 32
5200PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel
In Commercial Distribution

  • EBCI5100PRO0 ()

  • Channel Number 32
5100PRO

  • Multiple physiological signal amplifier
Height adjustable arm grounded, VESA 75/75, attached to vertical pole to be mouted to, horizontal rail, spring strength 600N
CIM med GmbH
PH-431C-TSM.gr1_60
In Commercial Distribution

  • 04061162104346 ()


  • Medical monitor/light mount
Height adjustable arm grounded, VESA 75/75, attached to vertical pole to be mouted to horizontal rail, spring strength 240N
CIM med GmbH
PH-431C-TSM.gr1_24
In Commercial Distribution

  • 04061162009931 ()


  • Medical monitor/light mount
3 Lead Continuous ECG Monitor & Arrhythmia Detector (Brigadier/Android/Verizon)
Lifewatch
MCT 3L-Brigadier-Verizon
In Commercial Distribution

  • 00850725007026 ()


  • Electrocardiography telemetric monitoring system transmitter
Samsung Health Body Composition tracker for android OS smart watch
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution

  • 08806092938854 ()


  • Bioelectrical body composition analyser
Samsung Health Body Composition tracker for android OS smart phone
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution

  • 08806092938847 ()


  • Bioelectrical body composition analyser
A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery.
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
GF1670
In Commercial Distribution

  • 00848657068796 ()
GF1670

  • Hand-held surgical retractor, reusable
IRRIGATION SET FOR MACHINERY Devices intended to convey the irrigation solution to the drill and/or to the surgical area to be treated during dental and maxillofacial surgery.
EURONDA SPA
IRRIGATION SET FOR MACHINERY
In Commercial Distribution

  • E3072709231 ()
  • E3072709230 ()
  • E3072709232 ()
270923

  • Surgical irrigation tubing set, single-use
IRRIGATION SET FOR MACHINERY Devices intended to convey the irrigation solution to the drill and/or to the surgical area to be treated during dental and maxillofacial surgery.
EURONDA SPA
IRRIGATION SET FOR MACHINERY
In Commercial Distribution

  • E3072709251 ()
  • E3072709250 ()
  • E3072709252 ()
270925

  • Surgical irrigation tubing set, single-use
Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
iOS
In Commercial Distribution

  • 04260749840015 ()


  • Self-care monitoring/reporting software
FINECROSS MG Coronary Micro-Guide Catheter
TERUMO CORPORATION
35-1450
In Commercial Distribution

  • 54987350703182 ()
  • 04987350703187 ()

  • Outer Diameter: 0.60 Millimeter
  • Length: 150 Centimeter
  • Clinically Relevant Size 1 is relative to the catheter distal end. And Clinically Relevant Size 2 is relative to the catheter proximal shaft.
NC*F865A

  • Vascular guide-catheter, single-use
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