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

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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NXC 2019-11-06

Vivid Aligners

Applicant Orthodent Laboratory, Inc.

K-Number K190003

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LPH 2019-11-06

Conformis Hip System

Applicant Conformis, Inc.

K-Number K192198

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JWY 2019-11-06

Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml

Applicant Thermo Fisher Scientific

K-Number K192729

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