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

MAX 2022-10-14

X-Pac Expandable Lumbar Cage System

Applicant Expanding Innovations, Inc.

K-Number K222797

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KOD 2022-10-13

allFlex Ureteral Catheters, Krait Ureteral Catheters

Applicant Allwin Medical Devices, Inc.

K-Number K220730

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PKP 2022-10-13

SCIg60 Infusion System

Applicant Emed Technologies Corporation

K-Number K222087

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DZE 2022-10-13

IM/ST Fixture System

Applicant Guilin Fiteeth Medical Instrument Co., Ltd.

K-Number K212702

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ONG 2022-10-13

Fiber Laser Treatment System

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K221770

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LON 2022-10-13

VITEK 2 AST-Gram Positive Cefoxitin Screen

Applicant bioMerieux, Inc.

K-Number K220805

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DYB 2022-10-13

Abiomed 14Fr Low Profile Introducer Set

Applicant Abiomed, Inc.

K-Number K222113

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IYN 2022-10-13

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)

Applicant Guangzhou Sonostar Technologies Co., Ltd.

K-Number K211321

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OUR 2022-10-13

UNITY Sacroiliac Joint Fixation System

Applicant Dio Medical Corporation

K-Number K222448

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DXQ 2022-10-13

Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201

Applicant Zhejiang Lude Technology Development Co., Ltd.

K-Number K221857

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GEI 2022-10-13

The Oligio

Applicant Wontech Co., Ltd.

K-Number K221989

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MBI 2022-10-13

Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors

Applicant Responsive Arthroscopy, LLC

K-Number K222763

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