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

GGZ 2020-04-06

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K200204

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KGO 2020-04-06

SensiCare PI and SensiCare PI Micro Surgical Gloves

Applicant Medline Industries, Inc.

K-Number K193217

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DQD 2020-04-06

Eko CORE

Applicant Eko Devices, Inc.

K-Number K200776

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LTK 2020-04-06

ADVIA Centaur CA 125II

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K200199

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KWQ 2020-04-06

Origin Anterior Cervical Plate System

Applicant Orthopaedic & Spine Development

K-Number K193494

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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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