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

MQC 2021-09-03

LuxaPrint Ortho Plus

Applicant Dmg Digital Enterprises SE

K-Number K210940

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ODC 2021-09-03

BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor

Applicant STERIS Corporation

K-Number K210342

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HIS 2021-09-03

Male Latex Condom

Applicant Global Protection Corp.

K-Number K203536

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EFB 2021-09-03

Dental Low-speed Handpieces and Accessories

Applicant Microp Technology (Taiwan), Inc.

K-Number K202786

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OVE 2021-09-03

C-CURVE Interbody Fusion Device

Applicant Medicrea International SA

K-Number K210470

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MSX 2021-09-03

Current Health Monitoring System Gen 2 (G2)

Applicant Current Health

K-Number K210133

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LLZ 2021-09-03

ADAS 3D

Applicant Adas3D Medical S.L.

K-Number K212421

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GEX 2021-09-03

AROMA GRAND

Applicant Daeju Meditech Engineering Co., Ltd.

K-Number K211637

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KWS 2021-09-03

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

Applicant Stryker GmbH

K-Number K210861

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FLL 2021-09-03

Infrared Thermometer, Model: HW-1

Applicant Dongguan Simzo Electronic Technology Co., Ltd.

K-Number K211583

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IRP 2021-09-02

Air Relax Pro Model AR-4.0

Applicant Diode Art Engineering Doing Business AS Air Relax

K-Number K212491

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JAK 2021-09-02

Lung Image Analysis

Applicant Pulmonx Corporation

K-Number K212494

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