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

MAX 2018-10-05

NuVasive Cohere Thoracolumbar Interbody System

Applicant Nu Vasive, Incorporated

K-Number K181860

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EYB 2018-10-04

Ureteric Catheters

Applicant Coloplast Corp.

K-Number K182122

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MOF 2018-10-04

HYBRID Guidewire

Applicant Balt USA, LLC

K-Number K182337

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JAK 2018-10-04

CURA 16; ScintCare CT16

Applicant Fmi Medical Systems, Inc.

K-Number K173076

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CEC 2018-10-04

MAGLUMI 2000 FT4

Applicant Shenzhen New Industries Biomedical Engineering Co., Ltd.

K-Number K182423

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NKB 2018-10-04

Prase MIS Spinal System

Applicant Gbs Commonwealth Co., Ltd.

K-Number K182059

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HRS 2018-10-04

WishBone Medical Plate and Screw System

Applicant Wishbone Medical, Inc.

K-Number K180736

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EOB 2018-10-04

Rhino-Laryngo Fiberscope Olympus ENF-GP2

Applicant Olympus Medical Systems Corp.

K-Number K181240

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MQB 2018-10-04

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

Applicant Pixxgen Corporation

K-Number K182533

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NOZ 2018-10-04

Diazyme 1,5-AG Assay

Applicant Diazyme Laboratories, Inc.

K-Number K180209

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NKG 2018-10-04

SYMPHONY™ OCT System

Applicant Medos International SARL

K-Number K181949

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IYE 2018-10-04

Encompass SRS Headframe ; Encompass MR SRS Headframe

Applicant Qfix

K-Number K182189

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