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

IRP 2019-10-29

Compression Therapy Device Model LGT-2200SP

Applicant Guangzhou Longest Science & Technology Co., Ltd.

K-Number K191862

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OLO 2019-10-29

Zimmer Biomet Universal Navigation System

Applicant Zimmer Biomet Spine, Inc.

K-Number K192133

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DZE 2019-10-29

W Zirconia Implants

Applicant Tav Medical , Ltd.

K-Number K192053

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NKB 2019-10-29

Black Diamond Pedicle Screw System

Applicant Osseus Fusion Systems

K-Number K192121

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IRP 2019-10-29

Game Ready GRPro 2.1 System

Applicant Cool Systems, Inc. (Dba Game Ready)

K-Number K192114

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PBX 2019-10-29

EmFace Device

Applicant Inmode MD , Ltd.

K-Number K191855

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NHA 2019-10-28

Straumann PUREloc abutments

Applicant Institut Straumann AG

K-Number K192029

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JOJ 2019-10-28

3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228

Applicant 3M Company

K-Number K192673

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GEI 2019-10-28

HS AMICA devices family

Applicant H.S Hospital Service S.P.A

K-Number K182605

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LEJ 2019-10-28

KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun

Applicant Kbl GmbH

K-Number K191881

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MAX 2019-10-28

3d Cage

Applicant Fims Co., Ltd.

K-Number K180347

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PND 2019-10-28

primeMidline Catheters

Applicant Pfm Medical, Inc.

K-Number K192802

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