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

EIH 2020-05-29

Dental Zirconia Blocks

Applicant De Corematrix Co., Ltd.

K-Number K192262

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OLO 2020-05-29

Stealthstation S8 Spine Software v1.3.0

Applicant Medtronic Navigation, Inc.

K-Number K201189

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GAR 2020-05-29

Crownjun Nylon Suture

Applicant Kono Seisakusho Co., Ltd.

K-Number K192420

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OVD 2020-05-29

Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device

Applicant 4Web, Inc.

K-Number K200002

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FMF 2020-05-29

Aspire Mechanical Aspirator G

Applicant Control Medical Technology

K-Number K200629

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PNO 2020-05-29

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter

Applicant Transit Scientific

K-Number K193495

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KXK 2020-05-29

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

Applicant Lv Liberty Vision Corporation

K-Number K193602

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IPL 2020-05-29

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08

Applicant Matia Robotics (Us), Inc.

K-Number K191334

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MAX 2020-05-29

Idys ALIF ZP 3DTi

Applicant Clariance, Sas

K-Number K200920

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DXN 2020-05-29

Automatic Digital Blood Pressure Monitor

Applicant Xiamen Ants Bro Technology Co., Ltd.

K-Number K190982

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GEH 2020-05-28

Frozen N

Applicant Yozma Bmtech Co., Ltd.

K-Number K193665

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LLZ 2020-05-28

Brainomix 360 e-CTA

Applicant Brainomix Limited

K-Number K192692

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