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

HHW 2018-10-31

Panpac Flexi Shelf Pessary

Applicant Panpac Medical Corporation

K-Number K173351

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FTL 2018-10-31

DynaMesh-POSTERIOR

Applicant Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft

K-Number K182087

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LLZ 2018-10-31

AVIEW

Applicant Coreline Soft Co., Ltd.

K-Number K171199

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NHA 2018-10-31

Universal Base Abutment

Applicant Nobel Biocare AB

K-Number K180899

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JWH 2018-10-31

Balanced Knee Revision System Trabecular Tibial Cone Augments

Applicant Ortho Development Corporation

K-Number K182085

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KPR 2018-10-31

Halifax Imaging Kit

Applicant Halifax Biomedical, Inc.

K-Number K182880

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FCG 2018-10-31

Single Use Aspiration Needle NA-U201H

Applicant Olympus Medical Systems Corp.

K-Number K181994

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NUJ 2018-10-31

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider

Applicant Surgical Instrument Service and Savings Inc.(Dba Medline Ren

K-Number K182588

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DIC 2018-10-31

Immunalysis Ethyl Alcohol Enzyme Assay

Applicant Immunalysis Corporation

K-Number K181553

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QDJ 2018-10-31

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

Applicant 23AndMe, Inc.

K-Number DEN180028

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NEU 2018-10-31

Tumark for Eviva, Tumark for Brevera

Applicant Somatex Medical Technologies GmbH

K-Number K182082

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HIG 2018-10-31

Endomat Select

Applicant Karl Storz SE & CO. KG

K-Number K180735

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