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

DRE 2022-08-24

TightRail Guardian Motorized Dilator Sheath

Applicant Spectranetics, Inc.

K-Number K212784

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NUH 2022-08-24

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K-Number K220998

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HQC 2022-08-24

miCOR System Lens Fragmentation System

Applicant Carl Zeiss Meditec Cataract Technology, Inc.

K-Number K222236

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FMI 2022-08-23

Disposable Medical Safety Hypodermic Needle

Applicant Hantech Medical Device Co., Ltd.

K-Number K220603

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GEX 2022-08-23

Picosecond Laser System (Model PS10-A and PS10-B)

Applicant Beijing Adss Development Co., Ltd.

K-Number K220268

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EMA 2022-08-23

Bifix Hybrid Abutment Cement

Applicant Voco GmbH

K-Number K220640

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HBE 2022-08-23

2.1 x 255mm Drill, 22mm Stop

Applicant Biomet Micofixation

K-Number K213072

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MBH 2022-08-23

GMK 3D Metal Tibial Tray

Applicant Medacta International S.A.

K-Number K221850

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QRL 2022-08-23

OneTouch Delica Plus Lancing System

Applicant Asahi Polyslider Co., Ltd.

K-Number K221546

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IYE 2022-08-23

ClearCheck Model RADCC V2

Applicant Radformation, Inc.

K-Number K220583

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EHD 2022-08-23

FONA XDC

Applicant Fona S.R.L

K-Number K222274

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MOS 2022-08-23

1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil

Applicant Invivo Corporation (Business Trade Name: Philips)

K-Number K222257

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