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

ODP 2020-12-28

Tailored-C Cervical Interbody Fusion System

Applicant Bespoke Technologies

K-Number K200458

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EHD 2020-12-28

Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)

Applicant Nanoray Co., Ltd.

K-Number K201800

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KDI 2020-12-28

Optiflux Series of Dialyzers F160NR, F180NR, F200NR

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K203062

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CBI 2020-12-28

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R

Applicant Insung Medical Co., Ltd.

K-Number K200968

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JWH 2020-12-28

Attune Revision Sleeve LPS Femoral Adaptors

Applicant Depuy Ireland UC

K-Number K202248

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LZO 2020-12-28

Quadra-P

Applicant Medacta International S.A.

K-Number K202730

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GWL 2020-12-27

8-CH Electroencephalography Amplifier

Applicant Hipposcreen Neurotech Corp.

K-Number K201747

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QNJ 2020-12-27

MBT Sepsityper

Applicant Bruker Daltonik GmbH

K-Number K193419

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POM 2020-12-25

ImPACT Version 4

Applicant Impact Applications, Inc.

K-Number K202485

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NFJ 2020-12-24

Image Quality Analyzer (IQA)

Applicant Visionquest Biomedical, Inc.

K-Number K200422

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MPB 2020-12-24

Acute Dual Lumen Hemodialysis Catheter

Applicant Health Line International Corporation

K-Number K200426

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GEX 2020-12-24

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories

Applicant Lumenis, Ltd.

K-Number K203544

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