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

GEX 2018-05-08

Empower H100, Cyber Ho 100, Litho 100

Applicant Quanta System Spa

K-Number K180922

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OVE 2018-05-08

A-CIFT SoloFuse

Applicant Spinefrontier, Inc.

K-Number K172484

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DRG 2018-05-08

BioStamp nPoint

Applicant Mc10, Inc.

K-Number K173510

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MAX 2018-05-08

STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX

Applicant Centinel Spine, Inc.

K-Number K173347

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HRS 2018-05-08

Trident Extremity Fixation System

Applicant Trident Orthopedics

K-Number K171690

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DEH 2018-05-08

VENTANA CD30 (Ber-H2) RxDx Assay

Applicant Ventana Medical Systems, Inc.

K-Number K172471

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BZQ 2018-05-07

Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation

Applicant Hill-Rom, Inc.

K-Number K180079

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GEI 2018-05-07

Endopath Electrosurgery Probe Plus II

Applicant Ethicon Endo-Surgery, LLC

K-Number K180031

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JOH 2018-05-07

Weinmann Tracheostomy Exchange Set

Applicant Cook Incorporated

K-Number K180034

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PDJ 2018-05-07

Afinion HbA1c Dx

Applicant Alere Technologies AS

K-Number K180296

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GWQ 2018-05-04

Trackit T4 EEG Amplifier

Applicant Lifelines , Ltd.

K-Number K172271

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PWJ 2018-05-04

Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left

Applicant Caldera Medical, Inc.

K-Number K172614

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