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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Andrews Pynchon Suction Stainless Steel Chrome Plated Quantum
SONTEC INSTRUMENTS, INC.
180-433Q
In Commercial Distribution

  • 00192896110090 ()

  • Tip 4.2 Millimeter
  • Length: 9.5 Inch


  • Surgical/emergency suction cannula, non-illuminating, reusable
Ryder Needle Holder Serrated 1 Millimeter Jaw Quantum
SONTEC INSTRUMENTS, INC.
2300-300Q
In Commercial Distribution

  • 00192896109858 ()

  • Length: 5 Inch


  • Suturing needle holder, reusable
Weil-Blakesley Rongeur Fenestrated Jaw Straight 5 Millimeters Quantum
SONTEC INSTRUMENTS, INC.
404-769Q
In Commercial Distribution

  • 00192896108608 ()

  • Length: 4.5 Inch


  • Orthopaedic joint/limb rongeur
Ruskin Rongeur Double Action Curved 2 Millimeters Quantum
SONTEC INSTRUMENTS, INC.
315-587Q
In Commercial Distribution

  • 00192896108479 ()

  • Length: 6 Inch


  • Orthopaedic joint/limb rongeur
Laryngoscopy Forceps Conical Tube Tip Angled Up Quantum
SONTEC INSTRUMENTS, INC.
1301-272Q
In Commercial Distribution

  • 00192896107359 ()

  • Length: 9 Inch
  • 2 Millimeter Shaft
  • 2.5 Millimeter Cup


  • Flexible endoscopic biopsy forceps, reusable
WESTCOTT TENOTOMY SCISSORS CURVED BLUNT MEDIUM BLADE QUANTUM
SONTEC INSTRUMENTS, INC.
13-3304Q
In Commercial Distribution

  • 00192896106703 ()

  • Length: 4.75 Inch


  • Ophthalmic suture scissors
WESTCOTT SCISSORS MEDIUM BLADE CURVED FENESTRATED HANDLE QUANTUM
SONTEC INSTRUMENTS, INC.
13-3308Q
In Commercial Distribution

  • 00192896106697 ()


  • Ophthalmic suture scissors
Wire Twister Tungsten Carbide Serrated Blunt Jaw Quantum
SONTEC INSTRUMENTS, INC.
2300-604Q
In Commercial Distribution

  • 00192896121379 ()

  • Length: 7 Inch
2300-604Q

  • Wire twister
McPherson-Westcott Conjunctival Scissors Small Curved Blunt Blades Quantum
SONTEC INSTRUMENTS, INC.
13-3300Q
In Commercial Distribution

  • 00192896121331 ()

  • Length: 4 Inch
13-3300Q

  • Conjunctival scissors, reusable
Par Needle Holder Tungsten Carbide Serrated Tip Quantum
SONTEC INSTRUMENTS, INC.
132-367AQ
In Commercial Distribution

  • 00192896117723 ()

  • Length: 4.5 Inch
132-367AQ

  • Suturing needle holder, reusable
HOUSE BELLUCCI EAR SCISSORS RIGHT CURVED BLADE QUANTUM
SONTEC INSTRUMENTS, INC.
469-087RQ
In Commercial Distribution

  • 00192896041387 ()

  • Length: 3.5 Inch
  • 4 Millimeter Blade
469-087RQ

  • Ear scissors, reusable
WIRE SUTURE SCISSORS SERRATED ANGLED 5.0 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-308Q
In Commercial Distribution

  • 00192896049673 ()

  • Length: 5 Inch
1100-308Q

  • Suture scissors
STRABISMUS SCISSORS STRAIGHT BLADE POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-020Q
In Commercial Distribution

  • 00192896047174 ()

  • Length: 4.5 Inch
1200-020Q

  • General-purpose surgical scissors, reusable
SPENCER SUTURE SCISSORS STRAIGHT DELICATE 4.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-298DQ
In Commercial Distribution

  • 00192896047167 ()

  • Length: 4.5 Inch
1100-298DQ

  • Suture scissors
Natus Quantum Amplifier system – 64 channels (phase II)
XLTEK
PK1258
In Commercial Distribution

  • 00382830048453 ()


  • Electroencephalograph
KIT, QUANTUM ULTIMATE INTENSIVE RESUSCITATION CARRY (Q.U.I.C.K.) - BASIC
NORTH AMERICAN RESCUE, LLC
35-0026
In Commercial Distribution

  • 00842209125159 ()
35-0026

  • Conduction blood/fluid warmer
  • First aid kit, non-medicated, single-use
Mayo Dissecting Scissors Classic Round Blades Straight Quantum
SONTEC INSTRUMENTS, INC.
1100-249Q
In Commercial Distribution

  • 00192896121928 ()

  • Length: 6 Inch
1100-249Q

  • General-purpose surgical scissors, reusable
software versions 3.10+ 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
3.10.0+
In Commercial Distribution

  • G140ANNALISEENTP60 ()
AnnaliseENTP6

  • X-ray image interpretive software
  • Radiology DICOM image processing application software
Software and sensor to provide assessment of respiratory capabilities.
ACCELERATED CARE PLUS CORP
ARASoftware
In Commercial Distribution

  • 00858703006344 ()


  • Pulmonary function analysis software, interpretive
  • Diagnostic spirometer, professional
Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.
Terarecon Inc.
Eureka AI Results Explorer
In Commercial Distribution

  • B2208430011 ()


  • Radiology DICOM image processing application software
No Description
RAPID Biomedical GmbH
10185782 02
In Commercial Distribution

  • 04260487680041 ()


  • MRI system coil, radio-frequency
No Description
Icad, Inc.
V2
Not in Commercial Distribution

  • 00858012005939 ()


  • Basic diagnostic x-ray system application software
No Description
Change Healthcare Canada Company
1.0.0
In Commercial Distribution

  • 17540262150018 ()


  • Radiological PACS 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
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
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
WILDE-ETHMOID RONGEUR STRAIGHT TIP ROUND ELIPTICAL FENESTRATED JAW QUANTUM
SONTEC INSTRUMENTS, INC.
468-600Q
In Commercial Distribution

  • 00192896079885 ()

  • Length: 4.5 Inch
  • 3 x 8 Millimeter Tip
468-600Q

  • Craniofacial rongeur, reusable
BAINBRIDGE FORCEPS DELICATE CURVED LONGITUDINAL CROSS SERRATED TIP QUANTUM
SONTEC INSTRUMENTS, INC.
115-602Q
In Commercial Distribution

  • 00192896075658 ()

  • Length: 6 Inch
115-602Q

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
CASTROVIEJO NEEDLE HOLDER WITHOUT LOCK DELICATE STRAIGHT JAW QUANTUM
SONTEC INSTRUMENTS, INC.
15-1880Q
In Commercial Distribution

  • 00192896074439 ()
15-1880Q

  • Suturing needle holder, reusable
CASTROVIEJO CORNEOSCLERAL SCISSORS SMALL/MEDIUM RIGHT ANGLED BLADES QUANTUM
SONTEC INSTRUMENTS, INC.
13-1306Q
In Commercial Distribution

  • 00192896072985 ()
13-1306Q

  • Corneal scissors, reusable
ALLIGATOR GRASPING FORCEPS DELICATE JAW LOCK 5.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-330SQ
In Commercial Distribution

  • 00192896089839 ()

  • Length: 5.5 Inch
1100-330SQ

  • Surgical soft-tissue manipulation forceps, alligator, reusable
ALLIGATOR GRASPING FORCEPS DELICATE SHAFT LOCK 6.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-333Q
In Commercial Distribution

  • 00192896089822 ()

  • Length: 6.5 Inch
1100-333Q

  • Surgical soft-tissue manipulation forceps, alligator, reusable
ADSON TISSUE FORCEPS WITH TYING PLATFORM SERRATED HANDLE QUANTUM
SONTEC INSTRUMENTS, INC.
136-674Q
In Commercial Distribution

  • 00192896088511 ()

  • 1 x 2 Teeth
  • Length: 4.75 Inch
136-674Q

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
MAYO SCISSORS BEVELED BLADES POWER CUT GOLD STRAIGHT QUANTUM
SONTEC INSTRUMENTS, INC.
1200-250Q
In Commercial Distribution

  • 00192896104822 ()

  • Length: 6.75 Inch


  • General-purpose surgical scissors, reusable
DOYEN-KOCHER INTESTINAL FORCEPS LONGITUDINAL SERRATIONS STRAIGHT 10.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1101-164Q
In Commercial Distribution

  • 00192896101289 ()

  • Length: 10.5 Inch


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
MAYO HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED STREAMLINE QUANTUM
SONTEC INSTRUMENTS, INC.
2300-714Q
In Commercial Distribution

  • 00192896100237 ()

  • Length: 5.75 Inch


  • Suturing needle holder, reusable
MAYO DISSECTING SCISSORS BEVELED BLADES TUNGSTEN CARBIDE CURVED QUANTUM
SONTEC INSTRUMENTS, INC.
1100-280Q
In Commercial Distribution

  • 00192896100183 ()

  • Length: 6.75 Inch
1100-280Q

  • General-purpose surgical scissors, reusable
LARYNGOSCOPY ALLIGATOR FORCEPS CONICAL TUBE CURVED LEFT TIP QUANTUM
SONTEC INSTRUMENTS, INC.
1301-214Q
In Commercial Distribution

  • 00192896100107 ()

  • Length: 9 Inch
  • 1 Millimeter Shaft
1301-214Q

  • Flexible endoscopic biopsy forceps, reusable
MAYO HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED STREAMLINED QUANTUM
SONTEC INSTRUMENTS, INC.
2300-726Q
In Commercial Distribution

  • 00192896099418 ()

  • Length: 10.25 Inch


  • Suturing needle holder, reusable
OPERATING SCISSORS SHARP/BLUNT STRAIGHT POWER CUT BLADES QUANTUM
SONTEC INSTRUMENTS, INC.
1200-214Q
In Commercial Distribution

  • 00192896099234 ()

  • Length: 5.5 Inch
1200-214Q

  • Bandage scissors, reusable
MAYO SCISSORS CURVED BEVELED BLADE POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-254Q
In Commercial Distribution

  • 00192896098534 ()

  • Length: 5.5 Inch
1200-254Q

  • General-purpose surgical scissors, reusable
MAYO SCISSORS STRAIGHT BEVELED BLADE POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-248Q
In Commercial Distribution

  • 00192896098527 ()

  • Length: 5.5 Inch
1200-248Q

  • General-purpose surgical scissors, reusable
NELSON METZENBAUM SCISSORS TUNGSTEN CARBIDE CURVED 14.0 IINCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-847Q
In Commercial Distribution

  • 00192896098480 ()

  • Length: 14 Inch
1100-847Q

  • Suture scissors
GOLDMAN-FOX SCISSORS TENOTOMY TIP POWER CUT GOLD CURVED QUANTUM
SONTEC INSTRUMENTS, INC.
1200-405Q
In Commercial Distribution

  • 00192896096936 ()

  • Length: 5 Inch
1200-405Q

  • Nasal scissors
MAYO DISSECTING SCISSORS BEVELED BLADES CURVED 5.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-254Q
In Commercial Distribution

  • 00192896094581 ()

  • Length: 5.5 Inch
1100-254Q

  • General-purpose surgical scissors, reusable
DUCKBILL ALLIGATOR GRASPING FORCEPS UP ANGLED 5.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-335Q
In Commercial Distribution

  • 00192896093591 ()

  • Length: 5.5 Inch
1100-335Q

  • Surgical soft-tissue manipulation forceps, alligator, reusable
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