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

HWC 2016-03-09

Biomet Variable Pitch Compression Screw System

Applicant Biomet, Inc.

K-Number K160058

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NAY 2016-03-09

da Vinci Single-Site Instrument and Accessories

Applicant Intuitive Surgical, Inc.

K-Number K152448

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MBI 2016-03-08

Ventix Knotless Anchors

Applicant Biomet Manufacturing Corp

K-Number K152262

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ELW 2016-03-08

CharmFlex

Applicant Dentkist, Inc.

K-Number K152766

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FTM 2016-03-08

SurgiPure XD Reconstructive Tissue Matrix

Applicant Tissue Regenix Group Plc

K-Number K152206

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GXY 2016-03-08

Mailuokang Self-adhesive Electrode

Applicant Shenzhen Mailuokang Technology Co., Ltd.

K-Number K152815

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IYE 2016-03-08

TruGuard Custom Tongue and Jaw Positioner

Applicant Bionix Development Corp.

K-Number K153270

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NKB 2016-03-08

Erisma-LP Spinal Fixation System

Applicant Clariance, Sas

K-Number K153326

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CAF 2016-03-08

Propeller System

Applicant Reciprocal Labs

K-Number K152882

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KWS 2016-03-08

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System

Applicant Zimmer GmbH

K-Number K160085

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MAX 2016-03-07

ProLift Expandable System

Applicant Life Spine, Inc.

K-Number K153400

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PMY 2016-03-07

Xpert Carba-R

Applicant Cepheid

K-Number K152614

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