Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

OLO 2022-07-07

SkyWalker Total Knee System

Applicant Microport Navibot International, LLC

K-Number K213873

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OHT 2022-07-07

IPL Hair Remover, Model: G993, G996, G998 and G885

Applicant Shenzhen Mywin Technology Co., Ltd.

K-Number K221679

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OHT 2022-07-07

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)

Applicant Shenzhen Semlamp Intelligent Technology Co., Ltd.

K-Number K221246

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EBI 2022-07-07

Stratasys TrueDent

Applicant Stratasys, Ltd.

K-Number K220771

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JOW 2022-07-07

medi pneumatic compression system (pcs)-genius (Model 652)

Applicant Medi USA, LP

K-Number K221654

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KWS 2022-07-07

AltiVate® Anatomic Shoulder AG e+ with Markers

Applicant Encore Medical L.P.

K-Number K213387

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OCT 2022-07-07

E-Brik Visualization Assistant

Applicant Jdi Surgical, Inc.

K-Number K221293

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OLP 2022-07-07

LED Facial Mask

Applicant Shenzhen Osto Technology Company Limited

K-Number K213056

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JIR 2022-07-06

Minuteful - kidney test

Applicant Healthy.Io, Ltd.

K-Number K210069

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LIT 2022-07-06

Oscar Peripheral Multifunctional Catheter system

Applicant Biotronik, Inc.

K-Number K214038

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KLE 2022-07-06

UniPrime A, UniPrime E, UniPrime E/C

Applicant S&C Polymer Silicon- Und Composite Spezialitäten GmbH

K-Number K221033

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FCG 2022-07-06

Disposable Biopsy Refill Needle

Applicant Suzhou Leapmed Healthcare Corporation

K-Number K212819

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