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

EBI 2017-11-02

Duracetal

Applicant The Myerson Company Limited

K-Number K172407

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GEH 2017-11-02

Compound W Nitro-Freeze

Applicant Medtech Products, Inc.

K-Number K172373

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ODP 2017-11-02

Sapphire Cervical Implant System

Applicant Sapphire Medical Group

K-Number K172674

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HSB 2017-11-02

DynaNail TTC Fusion System

Applicant MedShape, Inc.

K-Number K171376

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GEI 2017-11-02

Valleylab FX8 Electrosurgical Platform

Applicant Covidien, LLC

K-Number K172757

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MXC 2017-11-02

myMerlin(TM) Mobile Application Model APP1001

Applicant St Jude Medical

K-Number K173232

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FRC 2017-11-02

Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator

Applicant Terragene S.A.

K-Number K163646

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OLO 2017-11-02

Mako Partial Knee Application

Applicant Mako Surgical Corp.

K-Number K172301

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FAD 2017-11-02

BIOSOFT DUO DOUBLE LOOP URETERAL STENTS

Applicant Coloplast Corp.

K-Number K170422

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OVD 2017-11-02

SOVEREIGN™ Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K172328

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CAF 2017-11-02

InnoSpire Go

Applicant Respironics Respiratory Drug Delivery (Uk) , Ltd.

K-Number K170853

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DRG 2017-11-02

VitalPatch® VitalConnect Platform

Applicant Vitalconnect, Inc.

K-Number K163453

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