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

FLL 2018-09-24

Probe Covers for Thermometers

Applicant K-Jump Health Co., Ltd.

K-Number K180714

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IZL 2018-09-24

AMADEO M-DR mini, AMADEO M-AX mini

Applicant Oehm Und Rehbein GmbH

K-Number K182317

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LLZ 2018-09-24

iNtuition-T1 Mapping and T2/T2* Mapping

Applicant Terarecon,Inc.

K-Number K180916

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LPH 2018-09-24

REDAPT Porous Acetabular Shell

Applicant Smith & Nephew, Inc.

K-Number K181366

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FAD 2018-09-21

Malecot Nephrostomy Catheter/Stent Set

Applicant Cook Incorporated

K-Number K180029

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LZO 2018-09-21

DePuy Corail AMT Hip Prosthesis

Applicant Depuy France S.A.S.

K-Number K173960

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LLZ 2018-09-21

InVivo Web Viewer

Applicant Anatomage, Inc.

K-Number K181926

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DQA 2018-09-21

BB-613 Watch Oximeter

Applicant Bio-Beat Technologies , Ltd.

K-Number K181006

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MBI 2018-09-21

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K181769

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HEX 2018-09-21

Pocket Colposcope System

Applicant Hadleigh Health Technologies, LLC

K-Number K181034

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LON 2018-09-21

BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN

Applicant Becton, Dickinson and Company

K-Number K181665

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LYZ 2018-09-21

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)

Applicant Hebei Titans Hongsen Medical Technology Co., Ltd.

K-Number K182043

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