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

NAY 2021-02-10

da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments

Applicant Intuitive Surgical, Inc.

K-Number K203632

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LPH 2021-02-10

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing

Applicant Encore Medical L.P.

K-Number K203557

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MUD 2021-02-10

FORE-SIGHT ELITE Absolute Tissue Oximeter

Applicant Edwards Lifesciences, LLC

K-Number K203490

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FLL 2021-02-10

Infrared Forehead Thermometer

Applicant Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.

K-Number K201536

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HGX 2021-02-10

Hi bebe super (Models BT-150S and BT-150L)

Applicant Bistos Co., Ltd.

K-Number K200675

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PDQ 2021-02-10

DSG Connect Technology

Applicant Spineguard S.A.

K-Number K201454

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INI 2021-02-10

Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)

Applicant Dongguan Prestige Sporting Goods Co., Ltd.

K-Number K191897

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LOL 2021-02-09

LIAISON Anti-HAV

Applicant DiaSorin, Inc.

K-Number K210272

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GWO 2021-02-09

Stryker PEEK Customized Cranial Implant Kit

Applicant Stryker

K-Number K203055

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LLZ 2021-02-09

Synapse 3D, Synapse 3D Base Tools v6.1

Applicant Fujifilm Corporation

K-Number K203103

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OWB 2021-02-09

SmartCT R1.0

Applicant Philips Medical Systems Nederland B.V.

K-Number K201583

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FXX 2021-02-09

nPro Surgical Mask

Applicant Np Medical, Inc.

K-Number K203265

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