Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

OCX 2020-04-06

Irrigation Tubing with CO2 or Air

Applicant Keymed (Medical and Industrial Equipment) , Ltd.

K-Number K193250

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GEX 2020-04-06

Diode Laser Hair Removal System

Applicant Beijing Sano Laser S&T Development Co.,Ltd

K-Number K191970

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DQY 2020-04-06

Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter

Applicant Mivi Neurovascular

K-Number K192558

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HTN 2020-04-06

Akros Scruture Anchor LisFranc Repair Kit

Applicant Akros Medical

K-Number K200361

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FXX 2020-04-06

ClearMask Transparent Surgical Face Mask

Applicant Clearmask, LLC

K-Number K200576

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JWY 2020-04-06

MTS Lefamulin 0.016- 256 µg/mL

Applicant Liofilchem S. R. 1.

K-Number K200308

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HAW 2020-04-06

Neural Navigator

Applicant Soterix Medical, Inc.

K-Number K191422

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LSR 2020-04-06

Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit

Applicant Gold Standard Diagnostics

K-Number K200025

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LSR 2020-04-06

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

Applicant Gold Standard Diagnostics

K-Number K200023

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ODP 2020-04-06

Tryptik Ti

Applicant Spineart

K-Number K200312

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DXQ 2020-04-06

Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer

Applicant Honsun (Nantong) Co., Ltd.

K-Number K192500

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MUJ 2020-04-03

Eclipse Treatment Planning System v16.0

Applicant Varian Medical Systems, Inc.

K-Number K200608

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