Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

OLO 2023-04-21

Paradigm System

Applicant Proprio, Inc.

K-Number K222291

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KNW 2023-04-21

Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument

Applicant Geotek Medikal Ltd Sti

K-Number K223300

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MQC 2023-04-21

dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S

Applicant Dentona AG

K-Number K222604

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MVA 2023-04-20

STARband 3D

Applicant Orthomerica Products, Inc.

K-Number K223238

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NKB 2023-04-20

ArtFX Spinal Fixation System

Applicant Artfx Medical, LLC

K-Number K212220

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MRN 2023-04-20

Inomax DSIR

Applicant Mallinckrodt Manufacturing, LLC

K-Number K211153

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JAK 2023-04-20

Deep Learning Image Reconstruction

Applicant Ge Healthcare Japan Corporation

K-Number K230807

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KCT 2023-04-20

Neodent Implant System - Helix Short Surgical Kit Cases

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K223662

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LPL 2023-04-20

Precision1, Precision1 for Astigmatism

Applicant Alcon Laboratories, Inc.

K-Number K230785

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DWP 2023-04-20

SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe

Applicant Fehling Surgical Instruments, Inc.

K-Number K220981

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QEY 2023-04-20

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101

Applicant Thrombolex, Inc.

K-Number K222095

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OWI 2023-04-20

HILINE Fixation System

Applicant Globus Medical, Inc.

K-Number K230565

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