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

GKZ 2017-11-01

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

Applicant HORIBA ABX SAS

K-Number K170353

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NEU 2017-10-31

Cianna Medical SAVI Scout Reflector and SAVI Scout System

Applicant Cianna Medical, Inc.

K-Number K171767

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JPA 2017-10-31

Sysmex CS-5100

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K172333

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NUC 2017-10-31

JO Gelato Flavored Personal Lubricants

Applicant United Consortium

K-Number K172447

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LZO 2017-10-31

Trinity™ Dual Mobility System

Applicant Corin U.S.A. Limited

K-Number K170359

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IYN 2017-10-31

ALOKA ARIETTA 850

Applicant Hitachi Healthcare Americas Corporation

K-Number K171708

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MAX 2017-10-31

IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)

Applicant Huvexel Co. , Ltd.

K-Number K173080

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JEY 2017-10-31

Stryker Upper-Face AXS screws and Mid-Face AXS screws

Applicant Stryker

K-Number K172572

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FRC 2017-10-31

Anprolene SteriTest

Applicant Andersen Sterilizers, Inc.

K-Number K170427

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OLO 2017-10-31

iFuse Implant System- iFuse Navigation

Applicant SI-BONE, Inc.

K-Number K172268

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ELW 2017-10-31

Rapid HB, Rapid LB, Rapid MB

Applicant 3M Deutschland GmbH

K-Number K173318

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FLF 2017-10-31

Anprolene AN75 Ethylene Oxide Gas Sterilizer

Applicant Andersen Sterilizers, Inc.

K-Number K170432

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