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

IYN 2022-10-13

X-CUBE 50, X-CUBE 60

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K220857

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NKB 2022-10-13

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods

Applicant Medos-International Sarl

K-Number K222473

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OBZ 2022-10-13

SPIFE A1AT kit

Applicant Helena Laboratories, Corp.

K-Number K213396

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NXC 2022-10-13

CREOKORREKT Aligners

Applicant Creodent Prosthetics, Ltd.

K-Number K211427

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GEX 2022-10-13

PicoWay Laser System

Applicant Candela Corporation

K-Number K220853

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OAP 2022-10-13

ID-510 iRestore Elite

Applicant Freedom Laser Therapy, Inc.

K-Number K222081

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EBF 2022-10-12

TrusFIL-Flow Flowable Composite Restorative

Applicant Rizhao Huge Biomaterials Company, Ltd.

K-Number K221510

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DSH 2022-10-12

AT-Patch ECG Analysis System

Applicant Atsens Co., Ltd.

K-Number K203638

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NRQ 2022-10-12

PiezoImplant System

Applicant Rex Implants, Inc.

K-Number K211872

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FLE 2022-10-12

MOST-T Autoclave

Applicant Shinva Medical Instrument Co., Ltd.

K-Number K220102

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LPN 2022-10-12

Aqua Naina Plus Sterile Saline Solution

Applicant Chemtex USA, Inc.

K-Number K221263

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MXJ 2022-10-12

Elecsys HSV-1 IgG (08948844160)

Applicant Roche Diagnostics

K-Number K220923

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