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

KIF 2018-01-04

BIO-C SEALER

Applicant Angelus Industria DE Produtos Odontologicos S/A

K-Number K172701

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LPH 2018-01-04

Bone Screws 6.5mm

Applicant Lima Corporate S.P.A.

K-Number K172456

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CCK 2018-01-04

OmniCap

Applicant Respirion, Inc.

K-Number K171235

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MWI 2018-01-04

WAVE Clinical Platform

Applicant Excel Medical Electronics, LLC

K-Number K171056

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HRS 2018-01-04

Alians Elbow Locking Plating System

Applicant Newclip Technics

K-Number K171372

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PHX 2018-01-03

Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate

Applicant Biomet Manufacturing Corp

K-Number K172502

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BZD 2018-01-03

AirFit F20

Applicant Resmed, Ltd.

K-Number K170924

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NHA 2018-01-03

Straumann CARES Abutments CoCr

Applicant Institut Straumann AG

K-Number K172798

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MAX 2018-01-03

Juliet Ti LL

Applicant Spineart

K-Number K173702

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MRW 2018-01-03

Facet Screw Fixation System

Applicant U&I Corporation

K-Number K173198

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LRK 2018-01-02

Snorer's Friend

Applicant Scope Healthcare Technologies Pty, Ltd.

K-Number K171529

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IYN 2018-01-02

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System

Applicant Shenzhen Wisonic Medical Technology Co. , Ltd.

K-Number K163712

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