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

KWQ 2020-11-04

Z-Span Plate System

Applicant Zavation Medical Products, LLC

K-Number K202624

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GWG 2020-11-04

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)

Applicant Rebound Therapeutics

K-Number K201840

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MHX 2020-11-04

Monitor B125, Monitor B105

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K201941

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KCT 2020-11-04

Sweden & Martina Surgical Tray (Model ZSHORTY-INT)

Applicant Sweden & Martina S.P.A.

K-Number K182084

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PBX 2020-11-03

Palm NRG cellulite and muscle toning body device

Applicant Heat IN A Click

K-Number K191940

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MAX 2020-11-03

FlareHawk Interbody Fusion System

Applicant Integrity Implants, Inc.

K-Number K202198

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EBG 2020-11-03

PMMA Block

Applicant Huge Dental Material Co., Ltd.

K-Number K201683

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PLL 2020-11-03

Blue Beacon Submucosal Injectable Solution

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K200071

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GBM 2020-11-02

SpeediCath Compact Set

Applicant Coloplast

K-Number K192904

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GEI 2020-11-02

Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set

Applicant Ellusa, LLC

K-Number K202562

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ITI 2020-11-02

e-Motion M25

Applicant Alber GmbH

K-Number K192618

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GEH 2020-11-02

IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle

Applicant Galil Medical, Inc.

K-Number K203032

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