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

MAX 2018-10-05

SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices

Applicant Spineex, Inc.

K-Number K181531

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GXY 2018-10-05

Sense System with IBT Electrodes

Applicant Infinite Biomedical Technologies, LLC

K-Number K182112

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ONF 2018-10-05

SHINY RPL System

Applicant Ids, Ltd.

K-Number K181868

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NKG 2018-10-05

EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System

Applicant K2m, Inc.

K-Number K181603

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MCW 2018-10-05

B-Laser Atherectomy System

Applicant Eximo Medical, Ltd.

K-Number K181642

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DQO 2018-10-05

Royal Flush Plus High-Flow Catheter

Applicant Cook Incorporated

K-Number K180054

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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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