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
Icad, Inc.
V2
Not in Commercial Distribution

  • 00858012005939 ()


  • Basic diagnostic x-ray system application software
No Description
RAPID Biomedical GmbH
10185782 02
In Commercial Distribution

  • 04260487680041 ()


  • MRI system coil, radio-frequency
No Description
Change Healthcare Canada Company
1.0.0
In Commercial Distribution

  • 17540262150018 ()


  • Radiological PACS software
OrthoGrid Trauma AI for non-invasive software system that provides image analysis tools for trauma procedures
Orthogrid Systems, Inc.
2010-915-507
In Commercial Distribution

  • 00860003424841 ()


  • Orthopaedic fluoroscopic grid software
BEIGE/990011-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990011-SWH
In Commercial Distribution

  • 00850016231116 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990002-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990002-SWH
In Commercial Distribution

  • 00850016231024 ()


  • Air-conduction hearing aid, receiver-in-canal
Salmonella O Polyvalent A-I Kit Group: A, B, C, D, E, F, G, H, I
PRO-LAB, INCORPORATED
PLA003
In Commercial Distribution

  • 00817978020004 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
CTB software versions 2.3+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
2.3+
In Commercial Distribution

  • G140ANNALISECONTAINER70 ()
Annalisecontainer7

  • Radiology DICOM image processing application software
LOXON Set for Quantum table (set with two pieces)
Orfit Industries NV
33173
In Commercial Distribution

  • 05420028783801 ()


  • DNA-based tissue typing IVD, reagent
2-pin bar for Quantum couch 51.4 cm MR safe
Orfit Industries NV
33213
In Commercial Distribution

  • 05420028707630 ()


  • DNA-based tissue typing IVD, reagent
Natus Quantum Breakout to Base Cable, 16 ft (5m)
XLTEK
013414
In Commercial Distribution

  • 00382830016391 ()


  • Electrical-only medical device connection cable, reusable
Natus Quantum Breakout to Base Cable, 33 ft (10m)
XLTEK
013348
In Commercial Distribution

  • 00382830016384 ()


  • Electrical-only medical device connection cable, reusable
Vise Grip Pliers Locking Adjustable Jaw Stainless Steel Quantum
SONTEC INSTRUMENTS, INC.
1103-133SQ
In Commercial Distribution

  • 00192896114777 ()

  • Length: 7 Inch
1103-133SQ

  • Wire holding/twisting pliers
Ryder Needle Holder Tungsten Carbide Serrated Jaw Streamline Quantum
SONTEC INSTRUMENTS, INC.
2300-313Q
In Commercial Distribution

  • 00192896111332 ()

  • Length: 8 Inch
  • Jaw 1.5 Millimeter


  • Suturing needle holder, reusable
Jacobson-Gemini Mixter Forceps Right Angle Full Curved Tip Quantum
SONTEC INSTRUMENTS, INC.
150-355Q
In Commercial Distribution

  • 00192896110557 ()

  • Length: 9 Inch


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Crile Wood Needle Holder Tungsten Carbide Serrated Tip Quantum
SONTEC INSTRUMENTS, INC.
132-388Q
In Commercial Distribution

  • 00192896110434 ()

  • Length: 6 Inch


  • Suturing needle holder, reusable
Stevens Tenotomy Scissors Short Sharp Straight Pointed Blade Quantum
SONTEC INSTRUMENTS, INC.
13-8805Q
In Commercial Distribution

  • 00192896109698 ()

  • Length: 4.125 Inch


  • Tenotome
Mayo Hegar Needle Holder Tungsten Carbide Serrated Tip Quantum
SONTEC INSTRUMENTS, INC.
132-124Q
In Commercial Distribution

  • 00192896109667 ()

  • Length: 11 Inch


  • Suturing needle holder, reusable
Castroviejo Needle Holder Without Lock Standard Straight Tip Quantum
SONTEC INSTRUMENTS, INC.
15-1861Q
In Commercial Distribution

  • 00192896109636 ()

  • Length: 5.5 Inch


  • Suturing needle holder, reusable
Crile Wood Needle Holder Tungsten Carbide Serrated Tip Quantum
SONTEC INSTRUMENTS, INC.
132-217Q
In Commercial Distribution

  • 00192896109612 ()

  • Length: 11 Inch


  • Suturing needle holder, reusable
Killian Septum Speculum Thin Low-Profile 3.0 Inch Blades Quantum
SONTEC INSTRUMENTS, INC.
465-313Q
In Commercial Distribution

  • 00192896108776 ()

  • Length: 5.5 Inch
465-313Q

  • Nasal speculum, reusable
Killian Septum Speculum Thin Low-Profile 2.50 Inch Blades Quantum
SONTEC INSTRUMENTS, INC.
465-311Q
In Commercial Distribution

  • 00192896108769 ()

  • Length: 5.5 Inch
465-311Q

  • Nasal speculum, reusable
Killian Septum Speculum Thin Low-Profile 2.0 Inch Blades Quantum
SONTEC INSTRUMENTS, INC.
465-309Q
In Commercial Distribution

  • 00192896108752 ()

  • Length: 5.5 Inch
465-309Q

  • Nasal speculum, reusable
House-Bellucci Ear Scissors Delicate 5 Millimeter Blades Straight Quantum
SONTEC INSTRUMENTS, INC.
469-089Q
In Commercial Distribution

  • 00192896106987 ()

  • Length: 3.5 Inch


  • Ear scissors, reusable
HOUSE-BELLUCCI EAR SCISSORS DELICATE 8 MILLIMETER BLADES STRAIGHT QUANTUM
SONTEC INSTRUMENTS, INC.
469-093Q
In Commercial Distribution

  • 00192896106932 ()


  • Ear scissors, reusable
Reeh Stitch Scissors Ribbon Handle Straight Sharp Blades Quantum
SONTEC INSTRUMENTS, INC.
13-8324Q
In Commercial Distribution

  • 00192896113473 ()

  • Length: 4 Inch


  • Enucleation scissors, reusable
Needle Nose Locking Pliers Stainless Steel (22 Centimeters) Quantum
SONTEC INSTRUMENTS, INC.
1103-137SQ
In Commercial Distribution

  • 00192896111745 ()

  • Length: 8.6 Inch


  • Wire holding/twisting pliers
DeBakey Needle Holder Ring Handle Tungsten Carbide Smooth Quantum
SONTEC INSTRUMENTS, INC.
2300-397Q
In Commercial Distribution

  • 00192896110038 ()

  • Length: 7 Inch


  • Suturing needle holder, reusable
Crile Wood Needle Holder Tungsten Carbide Serrated Streamlined Quantum
SONTEC INSTRUMENTS, INC.
2300-388SQ
In Commercial Distribution

  • 00192896110021 ()

  • Length: 8 Inch


  • Suturing needle holder, reusable
Lewin Bone Holding Clamp With Long Double Ratchet Quantum
SONTEC INSTRUMENTS, INC.
1100-427Q
In Commercial Distribution

  • 00192896109940 ()

  • Length: 7 Inch


  • Bone approximation clamp
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