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

OHS 2022-12-08

LED Eye Perfector, model: EY-36A, EY-36B

Applicant Light Tree Ventures Europe B.V.

K-Number K221444

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LGZ 2022-12-08

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer

Applicant Quality IN Flow , Ltd.

K-Number K211800

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MOS 2022-12-08

InkSpace Imaging Body Array

Applicant Inkspace Imaging, Inc.

K-Number K223487

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QRY 2022-12-08

Yomi Robotic System

Applicant Neocis, Inc.

K-Number K222750

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QNR 2022-12-08

CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System

Applicant Abbott (Formerly Thoratec Corporation)

K-Number K222038

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IRP 2022-12-08

YY-A02-B Overlapped Compression Therapy

Applicant Huizhou Xinyi Technology Co., Ltd.

K-Number K221862

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JXG 2022-12-08

IRRAflow Active Fluid Exchange System (AFES)

Applicant Irras USA

K-Number K222471

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CAW 2022-12-08

Oxygen Concentrator, Model JAY-5AW

Applicant Longfian Scitech Co., Ltd.

K-Number K213210

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EZD 2022-12-08

Sleeved IC

Applicant Hollister Incorporated

K-Number K220667

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MCW 2022-12-08

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K-Number K222837

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MOS 2022-12-08

8ch Wrist Coil

Applicant Shenzhen RF Tech Co., Ltd.

K-Number K223239

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JDW 2022-12-08

MAVERICK Mini External Fixation System

Applicant Smith & Nephew, Inc.

K-Number K223112

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