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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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QUANTUM™* FLEX - 00846468022389

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-120
Not in Commercial Distribution

  • 00846468022389 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022372

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-110
Not in Commercial Distribution

  • 00846468022372 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022365

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-100
Not in Commercial Distribution

  • 00846468022365 ()


  • Bone-screw internal spinal fixation system, non-sterile

Quantum Intersegmental Table - 00850020142415

No Description
PIVOTAL HEALTH SOLUTIONS, INC.
Q400
In Commercial Distribution

  • 00850020142415 ()


  • Traction table, line-powered

Quantum 6000Z HD - 00606509200110

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Pride Mobility Products Corp
Quantum 6000ZHD/Q6000ZHD/Q600 HD
In Commercial Distribution

  • 00606509200110 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled

Quantum Mitohormesis (QMT) - 08885022060018

Quantum Mitohormesis (QMT) Medical Device is intended for: 1. Stimulating healthy limb muscles to improve and facilitate muscle performance. 2. Preventing or retardation of disuse atrophy of muscles.
QUANTUMTX PTE. LTD.
M2101
In Commercial Distribution

  • 18885022060015 ()
  • 08885022060018 ()


  • Muscle performance enhancement electromagnetic stimulator

16 Ch AI BREAST COIL 1.5T - 04260487680034

No Description
RAPID Biomedical GmbH
10185781 02
In Commercial Distribution

  • 04260487680034 ()


  • MRI system coil, radio-frequency

PowerLook AI Mammo Container 1.0.0 Blackford - 00850008977534

No Description
Icad, Inc.
DSC036-01
In Commercial Distribution

  • 00850008977534 ()


  • Radiology DICOM image processing application software

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586341

No Description
CAPTION HEALTH, INC.
Alastor
Not in Commercial Distribution

  • 00860003586341 ()


  • Ultrasound imaging system application software

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586310

Caption AI (Caption Guidance + Caption Interpretation) on portable handheld ultrasound. The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
Adonis
Not in Commercial Distribution

511-00019

  • Ultrasound imaging system application software

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586303

The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
0.10, 0.11, 1.1, 1.2, 1.3, 1.4
Not in Commercial Distribution

  • 00860003586303 ()
511-00003

  • Ultrasound imaging system application software

K-ASSAY® Apo AI / B Control - 00816426021648

For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
KAMIYA BIOMEDICAL COMPANY, LLC
K310C-4M
In Commercial Distribution

  • 00816426021648 ()
K310C-4M

  • Multiple apolipoprotein IVD, control

K-ASSAY® Apo AI / B Control - 00816426021631

For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
KAMIYA BIOMEDICAL COMPANY, LLC
K310C-2M
Not in Commercial Distribution

  • 00816426021631 ()
K310C-2M

  • Multiple apolipoprotein IVD, control

ALLIGATOR GRASPING FORCEPS - 00192896091467

ALLIGATOR GRASPING FORCEPS DELICATE SHAFT SMALL JAW LOCK 3.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-328SQ
In Commercial Distribution

  • 00192896091467 ()

  • Length: 3.5 Inch
1100-328SQ

  • Surgical soft-tissue manipulation forceps, alligator, reusable

SONTEC OLSEN-HEGAR NEEDLE HOLDER - 00192896088528

SONTEC OLSEN-HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP 6.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-108Q
In Commercial Distribution

  • 00192896088528 ()

  • Length: 6.5 Inch
1100-108Q

  • Suturing needle holder, reusable

Brown Adson Tissue Forceps - 00192896105447

BROWN ADSON TISSUE FORCEPS SERRATED HANDLE 7 X 7 TEETH QUANTUM
SONTEC INSTRUMENTS, INC.
136-688SQ
In Commercial Distribution

  • 00192896105447 ()

  • Length: 4.75 Inch


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Stevens Tenotomy Scissors - 00192896104082

STEVENS TENOTOMY SCISSORS POWER CUT GOLD SHORT TIP STRAIGHT BLUNT QUANTUM
SONTEC INSTRUMENTS, INC.
1200-050Q
In Commercial Distribution

  • 00192896104082 ()

  • Length: 4.125 Inch


  • Nasal scissors

LARYNGOSCOPY FORCEPS - 00192896095632

LARYNGOSCOPY FORCEPS RIGHT CURVED HEART SHAPED TIP CONICAL TUBE SHAFT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-256Q
In Commercial Distribution

  • 00192896095632 ()

  • 2 Millimeter Shaft
  • Length: 9 Inch
1301-256Q

  • Flexible endoscopic biopsy forceps, reusable

MICRO BIOPSY FORCEPS - 00192896100923

MICRO BIOPSY FORCEPS DELICATE STRAIGHT OVAL CUP BLACK ANODIZE COATED QUANTUM
SONTEC INSTRUMENTS, INC.
469-070BQ
In Commercial Distribution

  • 00192896100923 ()

  • Length: 3 Inch
  • 1.2 x 0.9 Millimeters Cup


  • Rigid endoscopic biopsy forceps, reusable

MAYO HEGAR NEEDLE HOLDER - 00192896100732

MAYO HEGAR NEEDLE HOLDER LEFT HANDED TUNGSTEN CARBIDE SERRATED TIP QUANTUM
SONTEC INSTRUMENTS, INC.
132-118LQ
In Commercial Distribution

  • 00192896100732 ()

  • Length: 7.25 Inch


  • Suturing needle holder, reusable

LARYNGOSCOPY FORCEPS - 00192896095625

LARYNGOSCOPY FORCEPS DOWNWARD ANGLE HEART SHAPED TIP CONICAL TUBE SHAFT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-268Q
In Commercial Distribution

  • 00192896095625 ()

  • Length: 9 Inch
  • 2 Millimeter Shaft
1301-268Q

  • Flexible endoscopic biopsy forceps, reusable

LARYNGOSCOPY FORCEPS - 00192896095618

LARYNGOSCOPY FORCEPS UPWARD ANGLE HEART SHAPED TIP CONICAL TUBE SHAFT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-266Q
In Commercial Distribution

  • 00192896095618 ()

  • 2 Millimeter Shaft
  • Length: 9 Inch
1301-266Q

  • Flexible endoscopic biopsy forceps, reusable

LARYNGOSCOPY FORCEPS - 00192896095601

LARYNGOSCOPY FORCEPS UP ANGLE HEART SHAPED TIP CONICAL TUBE SHAFT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-264Q
In Commercial Distribution

  • 00192896095601 ()

  • 45 Degree Tip
  • Length: 9 Inch
  • 2 Millimeter Shaft
1301-264Q

  • Flexible endoscopic biopsy forceps, reusable

ALLIGATOR GRASPING FORCEPS - 00192896093645

ALLIGATOR GRASPING FORCEPS DELICATE SHAFT DELICATE JAW LOCK 9.0 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-334Q
In Commercial Distribution

  • 00192896093645 ()

  • Length: 9 Inch
1100-334Q

  • Surgical soft-tissue manipulation forceps, alligator, reusable

ALLIGATOR GRASPING FORCEPS - 00192896092143

ALLIGATOR GRASPING FORCEPS DELICATE SHAFT LARGE JAW 3.0 INCHES BLACK QUANTUM
SONTEC INSTRUMENTS, INC.
1100-328LBQ
In Commercial Distribution

  • 00192896092143 ()

  • Length: 3 Inch
1100-328LBQ

  • Surgical soft-tissue manipulation forceps, alligator, reusable

Stevens Tenotomy Scissors - 00192896110960

Stevens Tenotomy Scissors Tungsten Carbide Power Cut Long Curved Blunt Quantum
SONTEC INSTRUMENTS, INC.
1200-499Q
In Commercial Distribution

  • 00192896110960 ()

  • Length: 4.5 Inch


  • Tenotome

Ryder Needle Holder - 00192896109902

Ryder Needle Holder Tungsten Carbide Serrated 1.5 Millimeter Jaw Streamlined Quantum
SONTEC INSTRUMENTS, INC.
2300-307Q
In Commercial Distribution

  • 00192896109902 ()

  • Length: 5 Inch


  • Suturing needle holder, reusable

Ryder Needle Holder - 00192896109834

Ryder Needle Holder Tungsten Carbide Serrated 1.5 Millimeter Jaw Streamlined Quantum
SONTEC INSTRUMENTS, INC.
2300-311Q
In Commercial Distribution

  • 00192896109834 ()

  • Length: 7 Inch


  • Suturing needle holder, reusable

Laryngoscopy Forceps - 00192896107182

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft Curved Right Alligator Quantum
SONTEC INSTRUMENTS, INC.
1301-212Q
In Commercial Distribution

  • 00192896107182 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107151

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft Angled Up Grasping Quantum
SONTEC INSTRUMENTS, INC.
1301-202Q
In Commercial Distribution

  • 00192896107151 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107144

LARYNGOSCOPY FORCEPS CONICAL TUBE 1 MILLIMETER SHAFT CURVED RIGHT GRASPING QUANTUM
SONTEC INSTRUMENTS, INC.
1301-204Q
In Commercial Distribution

  • 00192896107144 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107120

LARYNGOSCOPY FORCEPS CONICAL TUBE 1 MILLIMETER SHAFT ANGLED UP ALLIGATOR QUANTUM
SONTEC INSTRUMENTS, INC.
1301-210Q
In Commercial Distribution

  • 00192896107120 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

QUANTUM™ CT Overlay - 10841962111000

QUANTUM CT Overlay for Canon Aquilion CT for 244cm long cradle
Qfix
RT-4550TAQ2
In Commercial Distribution

  • 10841962111000 ()

  • Length: 244 Centimeter
RT-4550TAQ2

  • Indexed-immobilization patient positioning system

QUANTUM™ CT Overlay - 10841962109076

QUANTUM CT Overlay for Toshiba Aquilion CT For 215cm long cradle
Qfix
RT-4550TAQ
In Commercial Distribution

  • 10841962109076 ()

  • Length: 215 Centimeter
RT-4550TAQ

  • Indexed-immobilization patient positioning system

QUANTUM™ CT Overlay - 10841962109021

QUANTUM CT Overlay for Phillips Brilliance CT For 250cm long cradle
Qfix
RT-4550PBR
In Commercial Distribution

  • 10841962109021 ()

  • Length: 250 Centimeter
RT-4550PBR

  • Indexed-immobilization patient positioning system

Natus - 00382830016421

Natus Quantum Stim Daisy Chain Cable, 1 to 2, 41 in
XLTEK
013769
In Commercial Distribution

  • 00382830016421 ()


  • Electrical-only medical device connection cable, reusable

OLSEN HEGAR NEEDLE HOLDER - 00192896081130

OLSEN HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP HEAVY 7.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-110HQ
In Commercial Distribution

  • 00192896081130 ()

  • Length: 7.5 Inch
1100-110HQ

  • Suturing needle holder, reusable

MAYO-HEGAR NEEDLE HOLDER - 00192896085749

MAYO-HEGAR NEEDLE HOLDER WITH STREAMLINED BOX LOCK TUNGSTEN CARBIDE SERRATED TIP QUANTUM
SONTEC INSTRUMENTS, INC.
2300-718Q
In Commercial Distribution

  • 00192896085749 ()

  • Length: 7 Inch
2300-718Q

  • Suturing needle holder, reusable

Stevens Tenotomy Scissors - 00192896106291

STEVENS TENOTOMY SCISSORS TUNGSTEN CARBIDE POWER CUT STRAIGHT POINTED SHARP BLADES QUANTUM
SONTEC INSTRUMENTS, INC.
1200-490Q
In Commercial Distribution

  • 00192896106291 ()

  • Length: 4.5 Inch


  • Tenotome

Forceps - 00192896103603

ROCHESTER CARMALT FORCEPS LONG SERRATED WITH HATCH TIP STRAIGHT 8.0 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-151Q
In Commercial Distribution

  • 00192896103603 ()

  • Length: 8 Inch


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
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