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

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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MAX 2022-07-27

Pegasus-X Expandable PLIF System

Applicant GS Medical Co., Ltd.

K-Number K221687

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ETD 2022-07-27

Hummingbird Tympanostomy Tube System

Applicant Preceptis Medical, Inc.

K-Number K221254

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OLO 2022-07-27

Real Intelligence Cori

Applicant Blue Belt Technologies, Inc.

K-Number K220958

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FXX 2022-07-27

AOK 95A Medical Mask (20200049)

Applicant Aok Tooling Limited

K-Number K220876

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