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

MQE 2019-11-25

Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)

Applicant Allwin Medical Devices, Inc.

K-Number K190590

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OLT 2019-11-23

Cadwell Bolt Software

Applicant Cadwell Industries, Inc.

K-Number K190760

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NTK 2019-11-23

DEXIS CariVu 3-in-1 by KaVo

Applicant Kaltenbach & Voigt GmbH

K-Number K182712

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EIH 2019-11-22

Color Liquid, Vita Liquid

Applicant Zirkonzahn Srl

K-Number K190518

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LZO 2019-11-22

AMIStem-P Short Neck

Applicant Medacta International S.A.

K-Number K192126

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MQB 2019-11-22

EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP

Applicant DRTECH Corporation

K-Number K193017

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NAY 2019-11-22

Senhance Surgical System

Applicant Transenterix, Inc.

K-Number K192877

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KNT 2019-11-22

Navina Smart System, Navina Classic System

Applicant Dentsply Sirona

K-Number K190977

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EBF 2019-11-22

everX Flow

Applicant GC America, Inc.

K-Number K192260

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DQO 2019-11-22

Trevo Trak 21 Microcatheter

Applicant Stryker

K-Number K192122

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OMP 2019-11-22

PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)

Applicant Kci USA, Inc.

K-Number K190697

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JOJ 2019-11-22

3M™ Attest™ Steam Chemical Integrators

Applicant 3M Company

K-Number K191236

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