SEARCH RESULTS FOR: 2023(1891 results)

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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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Medis Suite XA - B141MEDISSUITEXA20230

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

AMG - 00850017650244

No Description
ARROW MEDSOURCE GROUP LIMITED
2023
Not in Commercial Distribution

  • 00850017650237 ()
  • 00850017650244 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

AMG - 00850017650237

No Description
ARROW MEDSOURCE GROUP LIMITED
2023
In Commercial Distribution

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


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

GEN4 Direct Access - 00840828108041

GEN4 Direct Access
CURBELL MEDICAL PRODUCTS, INC.
4C380U-Z103008
In Commercial Distribution

  • 00840828108041 ()
2023

  • Pillow speaker

LED Curing Light - D836PSLFH9

A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.
DENT ZAR, INC.
1
In Commercial Distribution

  • D836PSLFH9 ()
2023

  • Dental/surgical polymerization lamp

truSculpt iD - 00816722021427

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

DIO Parallel Pin - 08800049202197

No Description
DIO Corporation
PP 2023
In Commercial Distribution

  • 08800049202197 ()


  • Dental guided surgery reference pin

HEp-2000® Fluorescent ANA-Ro Test System - M7490202321

ANA Nucleolar Positive Control - 2 x 1 ml
IMMUNO CONCEPTS INC
2023 (2)
In Commercial Distribution

  • M7490202321 ()
2023 (2)

  • Multiple antinuclear antibody (ANA) screening IVD, control

IVA Cage - 08809557206031

TLIF(B) Trial L36 x W9 x H9
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557206031 ()
TI.2023

  • Spinal implant trial

Teknobios - G0602023T0

Diffuser of ready-to-use liquid solutions
Amil Care Corp.
1L-2L-5L (hub)
In Commercial Distribution

  • G0602023T0 ()
2023.t

  • Airborne device-disinfectant diffuser

Tinto Oct-2 RMab - L502BSB2023

Tinto Oct-2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • L502BSB2023 ()
BSB 2023

  • Oct-2 IVD, antibody

NICOLE MILLER - 00802807353927

SINGLE SUNGLASS
Evolutioneyes, Inc.
NM SUN 2023
In Commercial Distribution

  • 00802807353927 ()


  • Tinted non-prescription spectacles

MAX STUDIO - 00802807353903

SINGLE SUNGLASS
Evolutioneyes, Inc.
MS SUN 2023
In Commercial Distribution

  • 00802807353903 ()


  • Tinted non-prescription spectacles

MAX EDITION - 00802807353910

SINGLE SUNGLASS
Evolutioneyes, Inc.
ME SUN 2023
In Commercial Distribution

  • 00802807353910 ()


  • Tinted non-prescription spectacles

Ashvins - 04260648620039

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

  • 04260648620039 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software

EYEVAN7285 - 04571445051514

No Description
EYEVAN INC.
748 50 2023
In Commercial Distribution

  • 04571445051514 ()


  • Spectacle frame

EYEVAN7285 - 04571445049689

No Description
EYEVAN INC.
554 47 2023
In Commercial Distribution

  • 04571445049689 ()


  • Spectacle frame

EYEVAN7285 - 04571445048651

No Description
EYEVAN INC.
414 46 2023
In Commercial Distribution

  • 04571445048651 ()


  • Spectacle frame

EYEVAN7285 - 04571445035347

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

  • 04571445035347 ()


  • Spectacle frame

ESPEC - 00802807355129

SINGLE READER
Evolutioneyes, Inc.
4221 2023 DEMI MERLOT
In Commercial Distribution

  • 00802807355129 ()


  • Magnifying spectacles

Radiography 7000 M - 00884838115521

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

Core Values - 00017276235340

Advanced Waterproof, Fast Healing Hydrocolloid Gel Pad Bandages, all one size, 2 IN x 3 IN
HARMON STORES, INC.
017276235340
Not in Commercial Distribution

  • 10017276235347 ()
  • 00017276235340 ()
  • 60017276235342 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Rite Aid Pharmacy - 00011822472371

Antibacterial Flexible Fabric Sterile Bandages, all one size 3/4 IN x 3 IN (19 mm x 76 mm)
RITE AID CORPORATION
011822472371
Not in Commercial Distribution

  • 10011822472378 ()
  • 00011822472371 ()
  • 60011822472373 ()


  • Skin-cover adhesive strip, antimicrobial

N/A - 00081215031744

No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-1H2-12X20
Not in Commercial Distribution

  • 00081215031744 ()


  • Liposuction system cannula, single-use

DENVER SPLINT - 00893398002998

No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-4021-10NKP
Not in Commercial Distribution

  • 00893398002998 ()


  • External nasal splint

DENVER SPLINT - 00893398002981

No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-3000-10NKS
Not in Commercial Distribution

  • 00893398002981 ()


  • External nasal splint

DENVER SPLINT - 00893398002974

No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-3000-10NKP
Not in Commercial Distribution

  • 00893398002974 ()


  • External nasal splint

DENVER SPLINT - 00893398002967

No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-3000-10NKM
Not in Commercial Distribution

  • 00893398002967 ()


  • External nasal splint

DENVER SPLINT - 00893398002950

No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-3000-10NKL
Not in Commercial Distribution

  • 00893398002950 ()


  • External nasal splint

DENVER SPLINT - 00893398002943

No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-2000-10NKS
Not in Commercial Distribution

  • 00893398002943 ()


  • External nasal splint
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