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

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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OCT 2019-01-22

AMD Anti-Fog Solution

Applicant Advanced Medical Design Co., Ltd.

K-Number K181887

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NJM 2019-01-22

S-Line

Applicant Biocetec Co., Ltd.

K-Number K182193

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LNH 2019-01-22

O-Scan

Applicant Esaote, S.p.A.

K-Number K183685

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OHS 2019-01-22

LG PRA.L DERMA LED MASK

Applicant Lg Electronics.Inc

K-Number K183671

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FBN 2019-01-22

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

Applicant Boston Scientific Corporation

K-Number K183636

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FLL 2019-01-22

FEMON Banana Thermometer

Applicant Life Science Technology, Inc.

K-Number K180767

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IYN 2019-01-22

HM70A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K182894

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NKG 2019-01-22

M.U.S.T. Mini Extension

Applicant Medacta International S.A.

K-Number K182837

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