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

FXX 2022-11-16

KNH Surgical Face Mask

Applicant Knh Surgical Face Mask

K-Number K203528

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QIH 2022-11-16

BoneMRI v1.4

Applicant Mrlguidance B.V.

K-Number K221762

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EOB 2022-11-16

PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10

Applicant Pentax of America, Inc.

K-Number K220465

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KWQ 2022-11-16

Life Spine ALIF Buttress Plate System

Applicant Life Spine, Inc.

K-Number K222628

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DZE 2022-11-16

OmniTaper EV Dental Implants, DS Implants abutments with EV connection

Applicant Dentsply Sirona

K-Number K221094

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FYA 2022-11-16

Surgical Gown

Applicant Xianning Marveldas Protective Articles Co., Ltd.

K-Number K212812

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OAP 2022-11-16

Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)

Applicant Xtrallux, LLC

K-Number K222364

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GAM 2022-11-15

STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device

Applicant ETHICON, Inc.

K-Number K221744

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FMK 2022-11-15

Disposable Sterile Lancet

Applicant Tianjin Rilifine Medical Device Co., Ltd.

K-Number K222055

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QNR 2022-11-15

LifeSPARC System

Applicant Cardiacassist, Inc.

K-Number K211830

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HSB 2022-11-15

Gamma4 System

Applicant Stryker GmbH

K-Number K222309

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CAC 2022-11-15

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)

Applicant Haemonetics Corporation

K-Number K221722

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