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

NHT 2019-11-07

B. anthracis Real-time PCR Assay

Applicant Centers for Disease Control and Prevention

K-Number K192871

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KTT 2019-11-07

PRECICE Plating System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K192181

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GCJ 2019-11-07

Laparoscope Lens Shield Device (LENS)

Applicant Medeon Biodesign, Inc.

K-Number K192891

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KNW 2019-11-07

EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G

Applicant Bard Peripheral Vascular, Inc.

K-Number K192948

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ELW 2019-11-07

StoneBite and StoneBite scan

Applicant Dreve Dentamid GmbH

K-Number K190571

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LLZ 2019-11-07

MEDIP PRO

Applicant Medical IP Co., Ltd.

K-Number K191026

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PEB 2019-11-07

BioGenesis Fertility Lubricant

Applicant Good Clean Love, Inc.

K-Number K190872

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PIF 2019-11-07

Salem Sump Dual Lumen Stomach Tube with ENFit Connection

Applicant Cardinalhealth

K-Number K190923

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MQB 2019-11-07

DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless

Applicant Canon, Inc.

K-Number K192632

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EBG 2019-11-07

Portux CAD/CAM Disc

Applicant New Stetic, SA

K-Number K192153

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HRS 2019-11-07

DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile

Applicant Synthes (USA) Products, LLC

K-Number K192327

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EZL 2019-11-06

Silicone Foley Catheter

Applicant Biosensors International Pte, Ltd.

K-Number K182463

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