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

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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NFJ 2017-11-01

IMAGEnet 6 Ophthalmic Data System

Applicant Topcon Corporation

K-Number K171370

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NUH 2017-11-01

Mytens Model: BW-TSX

Applicant Bewell Connect Corp.

K-Number K171026

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MHX 2017-11-01

Monitor B125, Monitor B105

Applicant Ge Medical Systems (China) Co., Ltd.

K-Number K171580

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