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

LHI 2022-06-21

Vial Adapter Ø13mm

Applicant Avenir Performance Européenne Medical (Apem)

K-Number K220856

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NHA 2022-06-21

Sherlock

Applicant Open Implants, LLC

K-Number K220482

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MTD 2022-06-21

AcQMap 3D Imaging and Mapping Catheter, Model 900009

Applicant Acutus Medical, Inc.

K-Number K210766

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EFB 2022-06-21

Stainless Turbine

Applicant Nakanishi, Inc.

K-Number K203791

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LLZ 2022-06-21

Syngo Carbon Space VA20A

Applicant Siemens Healthcare GmbH

K-Number K213665

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IYN 2022-06-21

Venue Go

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K220800

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HBF 2022-06-20

NeuroLine Disposable Cranial Perforator with Hudson end

Applicant Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.

K-Number K213228

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OAB 2022-06-17

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode

Applicant Galvanize Therapeutics, Inc.

K-Number K212871

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MAX 2022-06-17

restor3d TiDAL Lumbar Interbody Fusion Device

Applicant Restor3D

K-Number K220523

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PIB 2022-06-17

IDx-DR v2.3

Applicant Digital Diagnostics, Inc.

K-Number K213037

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GCJ 2022-06-17

SPY Laparoscope

Applicant Stryker

K-Number K221217

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PPW 2022-06-17

CipherOx CRI Tablet

Applicant Flashback Technologies, Inc.

K-Number K213255

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