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

QBD 2022-07-28

MagXtract Collection Tube

Applicant Magbio Genomics, Inc.

K-Number K212113

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PCI 2022-07-28

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel

Applicant Becton, Dickinson and Company

K-Number K214122

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EOQ 2022-07-28

EXALT Model B Single-Use Bronchoscope

Applicant Boston Scientific Corporation

K-Number K222014

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LFL 2022-07-28

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, Inc.

K-Number K221235

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FRG 2022-07-27

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap

Applicant Owens & Minor (O&M) Halyard, Inc.

K-Number K214007

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FIP 2022-07-27

AquaA

Applicant Fresenius Medical Care Rental Therapies Group, LLC

K-Number K213507

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KPR 2022-07-27

OTC DDR

Applicant Konica Minolta Healthcare Americas, Inc.

K-Number K221853

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LZA 2022-07-27

Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Better Care Plastic Technology Co., Ltd.

K-Number K221269

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KYJ 2022-07-27

KeriFlex® MCP and PIP Finger Joint Prostheses

Applicant Keri Medical SA

K-Number K211385

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DXN 2022-07-27

Upper Arm Type Blood Pressure Monitor

Applicant Shenzhen Jamr Technology Co., Ltd.

K-Number K220886

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LKJ 2022-07-27

EliA Ro52, EliA Ro60

Applicant Phadia AB

K-Number K210902

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MXD 2022-07-27

BIOMONITOR IIIm, BIOMONITOR III

Applicant Biotronik, Inc.

K-Number K221856

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