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

LCX 2024-02-05

FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream

Applicant Assure Tech. (Hangzhou) Co, Ltd.

K-Number K233174

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MQV 2024-02-05

Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE

Applicant Bone Solutions, Inc.

K-Number K234013

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HSB 2024-02-05

Flow-Nail

Applicant Flow-Fx, LLC

K-Number K234075

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QIH 2024-02-05

Viz HDS, Viz Volume Plus, Viz ICH+

Applicant Viz. Ai, Inc.

K-Number K232363

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GWL 2024-02-04

X-trodes System M

Applicant X-Trodes

K-Number K232210

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GWM 2024-02-04

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)

Applicant Integra Lifesciences Production Corporation

K-Number K232890

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GEX 2024-02-02

Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)

Applicant Rhein Laser Technologies Co., Ltd.

K-Number K233756

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FED 2024-02-02

CVAC Aspiration System + CVAC Image Processor

Applicant Calyxo, Inc.

K-Number K233472

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FLL 2024-02-02

VitalDetect

Applicant Wellvii, Inc.

K-Number K231625

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GEX 2024-02-02

PiXel8-Reveal

Applicant Rohrer Aesthetics

K-Number K233143

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MQC 2024-02-02

Myoaligner Appliance

Applicant Myohealth Technologies, LLC

K-Number K230548

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BWF 2024-02-02

AllPEP

Applicant Enchant Tek Co. , Ltd.

K-Number K233855

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