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

KDI 2019-08-09

NxStage Cartridge Express with Speedswap

Applicant Nxstage Medical, Inc.

K-Number K183158

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IYN 2019-08-09

Versana Balance

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K191792

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HBE 2019-08-09

ELAN 4 Tools

Applicant Aesculap, Inc.

K-Number K183203

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GEX 2019-08-09

SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)

Applicant Olympus Surgical Technologies America

K-Number K183647

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IYN 2019-08-09

ARIETTA 750

Applicant Hitachi Healthcare Americas

K-Number K191233

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JWH 2019-08-08

iTotal Identity Cruciate Retaining Knee Replacement System

Applicant Conformis, Inc.

K-Number K190562

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LZO 2019-08-08

Conformity Stem

Applicant United Orthopedic Corporation

K-Number K183312

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NKB 2019-08-08

ARx Spinal System

Applicant Life Spine, Inc.

K-Number K191575

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QEP 2019-08-08

binx health io CT/NG Assay

Applicant Binx Health, Inc.

K-Number K191352

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FFX 2019-08-08

Transit-Pellets

Applicant Medifactia AB

K-Number K181760

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NHN 2019-08-08

Erchonia EVRL

Applicant Erchonia Corporation

K-Number K191257

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LPN 2019-08-08

REFRESH RELIEVA For CONTACTS

Applicant Allergan, Inc.

K-Number K190674

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