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

OCC 2017-08-30

Idylla Respiratory (IFV-RSV) Panel

Applicant Janssen Pharmaceutica NV

K-Number K163628

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CAF 2017-08-30

SmartTouch

Applicant Adherium (Nz), Ltd.

K-Number K163485

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HIR 2017-08-29

Feminine Personal Trainer (FPT)

Applicant Ralston Group

K-Number K171896

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MAI 2017-08-29

CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver

Applicant Conmed Corporation

K-Number K171592

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LNH 2017-08-29

SyMRI

Applicant Syntheticmr AB

K-Number K162943

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DZE 2017-08-29

Cortex Dental Implant System

Applicant Cortex Dental Implants Industries , Ltd.

K-Number K163385

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EWO 2017-08-29

Easyscreen

Applicant Maico Diagnostics GmbH

K-Number K171506

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GAW 2017-08-29

Assut Filbloc Permanent Sutures

Applicant Assut Europe S.P.A.

K-Number K171039

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MAX 2017-08-29

Altus Spine Titanium Interbody Fusion System

Applicant Altus Partners, LLC

K-Number K171329

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GCJ 2017-08-29

Laport

Applicant Sejong Medical Co., Ltd.

K-Number K171741

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DXC 2017-08-29

ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm

Applicant Tricol Biomedical, Inc.

K-Number K170958

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MEA 2017-08-29

ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

Applicant Summit Medical Products, Inc.

K-Number K162165

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