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FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

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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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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