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

HIH 2023-04-27

UNIDRIVE SIII System

Applicant Karl Storz-Endoscopy-America, Inc.

K-Number K223520

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PGW 2023-04-27

ENT EM

Applicant Brainlab AG

K-Number K223734

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GEI 2023-04-27

ArtiSential Laparoscopic Instruments-Electrodes

Applicant Livsmed, Inc.

K-Number K230539

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ELW 2023-04-27

DentMix VPS Impression Material

Applicant Innovative Product Brands, Inc.

K-Number K223892

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GEI 2023-04-27

Renuvion® APR Handpiece

Applicant Apyx Medical Corporation

K-Number K230272

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MYE 2023-04-27

Gastric Alimetry System

Applicant Alimetry , Ltd.

K-Number K223398

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FET 2023-04-26

EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100

Applicant Olympus Medical Systems Corporation

K-Number K222584

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NUH 2023-04-26

TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

Applicant Chongqing Rob Linka Science and Technology Co., Ltd.

K-Number K230829

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MAX 2023-04-26

PYXIS 3D Titanium Cage System

Applicant GS Medical Co., Ltd.

K-Number K223868

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GEI 2023-04-26

ArtiSential Laparoscopic Instruments-Electrodes

Applicant Livsmed, Inc.

K-Number K230499

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PTF 2023-04-26

Access PCT

Applicant Beckman Coulter, Inc.

K-Number K222996

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GEI 2023-04-26

SafeAir combi (SFR-combi-US)

Applicant Lina Medical Aps

K-Number K223932

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