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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20-23 Black Spectacle
Kenmark Optical, Inc.
2023BK53
In Commercial Distribution

  • 00715317081238 ()


  • Prescription spectacles
20-23 Grey Spectacle
Kenmark Optical, Inc.
2023GR53
In Commercial Distribution

  • 00715317081153 ()


  • Prescription spectacles
20-23 Sky Spectacle
Kenmark Optical, Inc.
2023SK53
In Commercial Distribution

  • 00715317081146 ()


  • Prescription spectacles
20-23 GA Tapered Blunt Tip
Beaver-Visitec International, Inc.
221266
In Commercial Distribution

  • 30886158010532 ()
  • 00886158010531 ()


  • Electrosurgical system
20-23 GA Tapered Fine Tip
Beaver-Visitec International, Inc.
221265
In Commercial Distribution

  • 30886158010525 ()
  • 00886158010524 ()


  • Electrosurgical system
Probe-Explorer, 20-23, Double-Ended, Tactile Tone™
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
EE2023
Not in Commercial Distribution

  • H834EE20230 ()
  • 10381780235071 ()
EE2023

  • Periodontal probe, reusable
Revised version of TR-ZX2 from 2023.
J.MORITA MFG.CORP.
TR-ZX2 Type PLUS
In Commercial Distribution

  • 04548213055999 ()


  • Dental surgical power tool motorized handpiece/set, electric
  • Endodontic apex locator
20-23 Gauge Blunt Point Bipolar Coagulation Pen
ION MEDICAL, INC.
202316
In Commercial Distribution

  • B91220231601 ()
  • B9122023162 ()


  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
20-23 Gauge Fine Point Bipolar Coagulation Pen
ION MEDICAL, INC.
202315
In Commercial Distribution

  • B9122023151 ()
  • B9122023152 ()


  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
BANDAGE WOVEN FINGERTIP
Prostat First Aid, LLC
2023
In Commercial Distribution

  • 00814889011206 ()


  • Adhesive bandage
Irrigation & Aspiration
HURRICANE MEDICAL INC
2023
In Commercial Distribution

  • 00813465010169 ()
  • 10813465010166 ()

  • Length: 22 Millimeter
  • Needle Gauge: 23 Gauge
2023

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Mosquito Forcep CVD 5"
K.T.SURGICO
2023
In Commercial Distribution

  • MASTER02 ()
  • TMS1732112 ()
  • KTS1222112 ()
KTS1222112

  • Surgical soft-tissue manipulation forceps, scissors-like, single-use
Adson Tissue (1x2) 4.75"
K.T.SURGICO
2023
In Commercial Distribution

  • MASTER05 ()
  • TMS1635712 ()
  • KTS1018012 ()
KTS1018012

  • Surgical soft-tissue manipulation forceps, tweezers-like, single-use
Adson Forcesp Serr. 4.75"
K.T.SURGICO
2023
In Commercial Distribution

  • MASTER04 ()
  • TMS1631412 ()
  • KTS1017012 ()
KTS1017012

  • Surgical soft-tissue manipulation forceps, tweezers-like, single-use
LITTAUER STITCH SCISSORS 4.5" STR
K.T.SURGICO
2023
In Commercial Distribution

  • MASTER0007 ()
  • KTS0880111 ()
  • TMS1539413 ()
KTS0880111

  • General-purpose surgical scissors, single-use
IRIS SCISSORS 4.5" STR LARGE RING
K.T.SURGICO
2023
In Commercial Distribution

  • MASTER001 ()
  • KTS0838511 ()
  • TMS1536411 ()
KTS0838511

  • General-purpose surgical scissors, single-use
Iris scissors str. 4.5"
K.T.SURGICO
2023
In Commercial Distribution

  • TMS1536411 ()
  • KTS0834211 ()
KTS0834211

  • General-purpose surgical scissors, single-use
OPERATING SCISSORS S/S 5.5" STR
K.T.SURGICO
2023
In Commercial Distribution

  • KTS0812014 ()
  • TMS1530214 ()
KTS0812014

  • General-purpose surgical scissors, single-use
OPERATING SCISSORS S/B 5.5" STR
K.T.SURGICO
2023
In Commercial Distribution

  • MASTER01 ()
  • TMS1530114 ()
  • KTS0811014 ()
KTS0811014

  • General-purpose surgical scissors, single-use
Operating scissors S/B str. 4.5"
K.T.SURGICO
2023
In Commercial Distribution

  • MASTER800 ()
  • KTS0811011 ()
  • TMS1530111 ()
KTS0880111

  • General-purpose surgical scissors, single-use
BEAUTIFIL FLOW PLUS F03 INC
SHOFU DENTAL CORPORATION
2023
In Commercial Distribution

  • E23520230 ()
2023

  • Dental composite resin
SINUS LIFT 1
Power Dental U.S.A. Inc.
2023
In Commercial Distribution

  • D9432023 ()
2023

  • Dressing/utility forceps, scissors-like, reusable
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Band Bag 20" X 23"
STERIMED LLC
2023
In Commercial Distribution

  • 20850341007206 ()
  • 10850341007209 ()
  • 00850341007202 ()


  • X-ray system cover
No Description
ARROW MEDSOURCE GROUP LIMITED
2023
Not in Commercial Distribution

  • 00850017650237 ()
  • 00850017650244 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
ARROW MEDSOURCE GROUP LIMITED
2023
In Commercial Distribution

  • 10850017650234 ()
  • 00850017650237 ()
  • 00850017650398 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Micro-OSMETTE Sample Tubes, 50 ul, 500/pk
Precision Systems, Inc.
2023
In Commercial Distribution

  • 00850041049236 ()
2023

  • General laboratory container, single-use
Medis Suite XA 2023 is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by Medis Suite XA 2023 are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.
Medis Medical Imaging Systems B.V.
2023
In Commercial Distribution



  • Laboratory instrument/analyser application software IVD
Medis Suite MRCT 2023 is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, Medis Suite MRCT 2023 allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT 2023 can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by Medis Suite MRCT 2023 are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.
Medis Medical Imaging Systems B.V.
2023
In Commercial Distribution



  • Laboratory instrument/analyser application software IVD
No Description
PROTEK MEDICAL PRODUCTS, INC.
2023
In Commercial Distribution

  • 10841912106872 ()
  • 00841912106875 ()
2023

  • Intraoperative ultrasound imaging transducer cover
No Description
MASIMO CORPORATION
2023
In Commercial Distribution

  • 00843997011150 ()


  • Electrical-only medical device connection cable, reusable
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