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
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
Micro-OSMETTE Sample Tubes, 50 ul, 500/pk
Precision Systems, Inc.
2023
In Commercial Distribution

  • 00850041049236 ()
2023

  • General laboratory container, single-use
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
No Description
MASIMO CORPORATION
2023
In Commercial Distribution

  • 00843997011150 ()


  • Electrical-only medical device connection cable, reusable
Calibration Standard Metanephrines
Chromsystems Instruments + Chemicals GmbH
2023
In Commercial Distribution

  • 04250317503114 ()

  • 10ml
2023

  • Multiple biogenic amine neurotransmitter IVD, calibrator
No Description
PROTEK MEDICAL PRODUCTS, INC.
2023
In Commercial Distribution

  • 10841912106872 ()
  • 00841912106875 ()
2023

  • Intraoperative ultrasound imaging transducer cover
GEN4 Direct Access
CURBELL MEDICAL PRODUCTS, INC.
4C380U-Z103008
In Commercial Distribution

  • 00840828108041 ()
2023

  • Pillow speaker
truSculpt iD RF Device (Rebranded as truSculpt RF Device in June 2023)
CUTERA, INC.
truSculpt iD
In Commercial Distribution

  • 00816722021427 ()


  • Radio-frequency skin contouring system
No Description
DIO Corporation
PP 2023
In Commercial Distribution

  • 08800049202197 ()


  • Dental guided surgery reference pin
TLIF(B) Trial L36 x W9 x H9
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557206031 ()
TI.2023

  • Spinal implant trial
SINGLE SUNGLASS
Evolutioneyes, Inc.
NM SUN 2023
In Commercial Distribution

  • 00802807353927 ()


  • Tinted non-prescription spectacles
SINGLE SUNGLASS
Evolutioneyes, Inc.
ME SUN 2023
In Commercial Distribution

  • 00802807353910 ()


  • Tinted non-prescription spectacles
SINGLE SUNGLASS
Evolutioneyes, Inc.
MS SUN 2023
In Commercial Distribution

  • 00802807353903 ()


  • Tinted non-prescription spectacles
No Description
EYEVAN INC.
748 50 2023
In Commercial Distribution

  • 04571445051514 ()


  • Spectacle frame
No Description
EYEVAN INC.
554 47 2023
In Commercial Distribution

  • 04571445049689 ()


  • Spectacle frame
No Description
EYEVAN INC.
414 46 2023
In Commercial Distribution

  • 04571445048651 ()


  • Spectacle frame
No Description
EYEVAN INC.
#414 46 2023
In Commercial Distribution

  • 04571445035347 ()


  • Spectacle frame
No Description
MedicalCommunications GmbH
2023 (Build 2088)
In Commercial Distribution

  • 04260648620039 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
SINGLE READER
Evolutioneyes, Inc.
4221 2023 DEMI MERLOT
In Commercial Distribution

  • 00802807355129 ()


  • Magnifying spectacles
Radiography 7000 M digital mobile is a new motorized mobile x-ray system that includes: 1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023) 2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories 3. Eleva WorkSpot In addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed - Grid Landsc. SkyPlateE Large - Grid Landscape SkyPlate Large - Grid Portr. SkyPlate E Large - Grid Portrait SkyPlate Large - Grid Portrait SkyPlate Small - Handle for Skyplate Large - Portable Panel Protector - Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large) - Set of 50 WPD Hygienic Bags (small)
Philips Medical Systems DMC GmbH
712010
In Commercial Distribution

  • 00884838115521 ()


  • Mobile basic diagnostic x-ray system, digital
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