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

GYB 2019-07-19

Tech Dots - Adhesive and conductive gel

Applicant Spes Medica Srl

K-Number K190050

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PJJ 2019-07-19

STERIZONE(R) VP4 Sterilizer

Applicant Tso3, Inc.

K-Number K190260

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FFL 2019-07-18

Peralta Stone Removal Catheter

Applicant Calcula Technologies, Inc.

K-Number K190492

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MAX 2019-07-18

FAVO S-TLIF

Applicant Silony Medical GmbH

K-Number K190680

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HSB 2019-07-18

AOS ES Retrograde Femoral Nail

Applicant Advanced Orthopaedic Solutions, Inc.

K-Number K191598

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QCC 2019-07-18

DreaMed Advisor Pro

Applicant DreaMed Diabetes, Ltd.

K-Number K191370

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MTJ 2019-07-18

MONTAGE-QS Settable, Resorbable Hemostatic Bone

Applicant Orthocon, Inc.

K-Number K191140

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DXT 2019-07-18

ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit

Applicant Acist Medical Systems, Inc.

K-Number K191060

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EIA 2019-07-18

Qraypen

Applicant AIOBIO Co., Ltd.

K-Number K183121

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NGX 2019-07-18

BionicGym Powered Muscle Stimulator

Applicant Medical Currents, Ltd.

K-Number K182794

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CBK 2019-07-18

Trilogy Evo

Applicant Respironics, Inc.

K-Number K181166

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NKG 2019-07-18

MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System

Applicant Medos International SARL

K-Number K190895

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