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

IMJ 2019-01-24

BTL-703

Applicant BTL Industries, Inc.

K-Number K182363

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IYN 2019-01-24

E-CUBE i7

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K182594

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FXX 2019-01-24

Surgical Face Mask

Applicant Xiantao Zhibo Non-Woven Products Co., Ltd.

K-Number K182514

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DRG 2019-01-24

Surveyor S2

Applicant Mortara Instrument, Inc.

K-Number K182297

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IZI 2019-01-23

SPY Elite Intraoperative Perfusion Assessment System

Applicant Novadaq Technologies Ulc. (Now A Part of Stryker)

K-Number K182907

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CFN 2019-01-23

Optilite IgA CSF Kit

Applicant The Binding Site Group , Ltd.

K-Number K183151

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MIB 2019-01-23

Pre-Formed Penile Silicone Block

Applicant International Medical Devices, Inc.

K-Number K181387

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DQA 2019-01-23

Masimo MightySat Rx Fingertip Pulse Oximeter

Applicant Masimo Corporation

K-Number K181956

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JWH 2019-01-22

Freedom Ultra-Congruent CR Tibial Liner

Applicant Maxx Orthopedics, Inc.

K-Number K182574

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NKB 2019-01-22

EUROPA™ Pedicle Screw System

Applicant MiRus, LLC

K-Number K182970

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MBF 2019-01-22

Compress and Mini Compress Anti-Rotation Spindles

Applicant Biomet, Inc.

K-Number K183553

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HWC 2019-01-22

EZStart Interference Screw

Applicant Conmed Corporation

K-Number K182955

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