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

HBE 2019-07-19

Anspach Helix Dissection Tools

Applicant The Anspach Effort, Inc.

K-Number K183545

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QAI 2019-07-19

Exceed Microneedling device

Applicant Mt. Derm GmbH

K-Number K182407

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OVB 2019-07-19

SpaceOAR Vue Hydrogel

Applicant Augmenix, Inc.

K-Number K182971

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KDI 2019-07-19

Surdial DX Hemodialysis System

Applicant Nipro Medical Corporation

K-Number K182940

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PBH 2019-07-19

KIDScore D3

Applicant Vitrolife A/S

K-Number K182798

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NQQ 2019-07-19

NvisionVLE Low-profile Optical Probe

Applicant Ninepoint Medical, Inc.

K-Number K191117

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IYN 2019-07-19

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0

Applicant Canon Medical Systems Corporation

K-Number K191467

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GBM 2019-07-19

Infyna Chic

Applicant Hollister Incorporated

K-Number K191633

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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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