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

QJP 2023-09-14

SOFIA EX Intracranial Support Catheter

Applicant MicroVention, Inc.

K-Number K230775

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MQC 2023-09-14

Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)

Applicant Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.

K-Number K230237

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OAS 2023-09-14

Provecta 3D Prime and Provecta 3D Prime Ceph

Applicant Durr Dental SE

K-Number K232487

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LLZ 2023-09-14

NEUROShield

Applicant In-Med Prognostics L3c

K-Number K220034

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BZR 2023-09-14

FlowStar Analog Mixer Flowmeter

Applicant Baldus Sedation GmbH & Co. KG

K-Number K230987

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IPF 2023-09-14

BACK 4

Applicant Swims America Corp

K-Number K230167

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OHT 2023-09-14

IPL Hair Removal, Model: W-1095, W-1098

Applicant Shenzhen Wochuan Electronic Co., Ltd.

K-Number K232124

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OVE 2023-09-14

ChoiceSpine Blackhawk Ti Cervical Spacer System

Applicant Choice Spine, LLC

K-Number K223869

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LLZ 2023-09-14

OrionXR

Applicant Hoth Intelligence, Inc.

K-Number K232189

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MQV 2023-09-14

Cove Putty, OsteoCove Putty

Applicant SeaSpine Orthopedics Corporation

K-Number K231030

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HTY 2023-09-14

Hammerdesis Interphalangeal Fusion System

Applicant Intelivation

K-Number K231147

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KPS 2023-09-14

cNeuro cPET

Applicant Combinostics OY

K-Number K231576

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