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

OUR 2021-02-25

iFuse-TORQ™ Implant System

Applicant SI-BONE, Inc.

K-Number K203247

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GZJ 2021-02-24

BioWaveGO RX

Applicant Biowave Corporation

K-Number K210202

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QEW 2021-02-24

Triever Catheters

Applicant Inari Medical

K-Number K210195

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LZA 2021-02-24

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

Applicant Gmp Medicare Sdn. Bhd.

K-Number K202003

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HRS 2021-02-24

ExtremiLOCK Lateral Ankle Fusion Plates

Applicant Osteomed

K-Number K203479

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EKX 2021-02-24

PROXEO Twist Cordless Polishing System PL-40 H

Applicant W&H Dentalwerk Buermoos GmbH

K-Number K201703

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OLO 2021-02-24

Practical Navigation Surgical Guidance System (PNSGS)

Applicant Practical Navigation, LLC

K-Number K202184

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NFO 2021-02-24

Trinity ELE Plus and Trinity ELE Plus Pro

Applicant Carol Cole Company Dba Nuface

K-Number K201906

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MAI 2021-02-24

CITRESPLINE and CITRELOCK ACL Implants

Applicant Acuitive Technologies, Inc.

K-Number K210239

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PBY 2021-02-24

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

Applicant Sirius Medical Systems B.V.

K-Number K200734

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GCJ 2021-02-24

4K UHD Laparoscope

Applicant Scivita Medical Technology Co., Ltd.

K-Number K203255

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IYN 2021-02-23

Lumify Diagnostic Ultrasound System

Applicant Philips Ultrasound, Inc.

K-Number K203406

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