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
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
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
No Description
MASIMO CORPORATION
2023
In Commercial Distribution

  • 00843997011150 ()


  • Electrical-only medical device connection cable, reusable
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
WellSky Transfusion 2023 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2023 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT 128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional) WellSky Transfusion 2023 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2023
Not in Commercial Distribution

  • B105TRANSFUSION2023 ()


  • Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match • Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2023
In Commercial Distribution

  • B105BLOODCENTERS2023 ()


  • Blood bank information system application software
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
Calibration Standard Metanephrines
Chromsystems Instruments + Chemicals GmbH
2023
In Commercial Distribution

  • 04250317503114 ()

  • 10ml
2023

  • Multiple biogenic amine neurotransmitter IVD, calibrator
GEN4 Direct Access
CURBELL MEDICAL PRODUCTS, INC.
4C380U-Z103008
In Commercial Distribution

  • 00840828108041 ()
2023

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

  • 00816722021427 ()


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

  • 08800049202197 ()


  • Dental guided surgery reference pin
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