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FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

EIH 2023-12-01

Dental Glass Ceramics Blocks

Applicant Aibodent Biotechnology Co., Ltd.

K-Number K232438

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FRO 2023-12-01

Antibacterial Gel Wound Dressing

Applicant Winner Medical Co., Ltd.

K-Number K231057

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QIH 2023-12-01

Syngo Carbon Clinicals

Applicant Siemens Healthcare GmbH

K-Number K232856

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GEI 2023-12-01

LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes

Applicant Surgical Principals, Inc.

K-Number K230621

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HTY 2023-12-01

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail

Applicant OSSIO , Ltd.

K-Number K231272

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KGN 2023-12-01

Comatryx OTC

Applicant Strukmyer Medical, LLC

K-Number K232758

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GEX 2023-12-01

ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories

Applicant Lumenis Be, Ltd.

K-Number K233301

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DQA 2023-11-30

Wrist Pulse Oximeter

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K230587

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GEX 2023-11-30

Q-Switched Nd:Yag laser

Applicant Hebei Zhemai Technology Co., Ltd.

K-Number K232716

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JAK 2023-11-30

syngo.CT Dual Energy

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232155

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IYN 2023-11-30

EPIQ Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K233545

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FAN 2023-11-30

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

Applicant Surgease Innovations Limited

K-Number K232262

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