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

HKI 2018-12-21

3nethra neo

Applicant Forus Health Pvt.Ltd

K-Number K183059

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FLL 2018-12-21

Disposable Temperature Probe

Applicant Shenzhen Caremed Medical Technology Co., Ltd.

K-Number K182755

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GAW 2018-12-21

REXLENE

Applicant Sm Eng Co., Ltd.

K-Number K173747

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ISA 2018-12-21

OrthoGold 100

Applicant Tissue Regeneration Technologies

K-Number K182682

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CGA 2018-12-21

PTS Professional Chemistry Kit

Applicant Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

K-Number K182781

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MBI 2018-12-21

2.8 mm/3.3 mm PopLok Suture Anchors

Applicant Conmed Corporation

K-Number K181120

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JKR 2018-12-21

ADVIA Centaur Calcitonin (CALCT) assay

Applicant Axis-Shield Diagnostics Limited

K-Number K182012

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HRS 2018-12-21

TruMatch Graft Cage - Long Bone

Applicant Synthes (Usa), LLC

K-Number K180821

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DQA 2018-12-21

vital signs monitor

Applicant Edan Instruments, Inc.

K-Number K180380

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NHA 2018-12-21

DIO CAD/CAM Abutment

Applicant Dio Corporation

K-Number K181037

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KWS 2018-12-21

Arthrex Fracture Adapter Hemi Shoulder Prosthesis

Applicant Arthrex, Inc.

K-Number K181555

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OOE 2018-12-21

LENSAR Laser System - fs 3D (LLS-fs 3D)

Applicant Lensar, Inc.

K-Number K182795

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