Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

JOW 2019-07-19

AeroDVx System

Applicant Sun Scientific, Inc.

K-Number K183349

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NKB 2019-07-19

Mariner MIS Pedicle Screw System; SeaSpine Navigation System

Applicant SeaSpine Orthopedics Corporation

K-Number K191648

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LLZ 2019-07-19

syngo.via MI Workflows VB40A, Scenium

Applicant Siemens Medical Soultions USA, Inc.

K-Number K191309

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NKB 2019-07-19

EUROPA Pedicle Screw System

Applicant MiRus, LLC

K-Number K191757

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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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