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

NXC 2023-05-22

3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)

Applicant 3M Company, Unitek Orthodontic Products

K-Number K231464

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QJP 2023-05-22

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support

Applicant Imperative Care, Inc.

K-Number K231168

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LJE 2023-05-22

Introducer Needle

Applicant Youcare Technology Co.,Ltd. (Wuhan)

K-Number K222705

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JWH 2023-05-19

Klassic Knee Revision System

Applicant Total Joint Othopedics, Inc.

K-Number K230537

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QFG 2023-05-19

iLet® ACE Pump

Applicant Beta Bionics, Inc.

K-Number K223846

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LLZ 2023-05-19

Autoplaque

Applicant Cedars-Sinai Medical Center: Aim

K-Number K212758

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QOI 2023-05-19

SafeBreak® Vascular

Applicant Lineus Medical

K-Number K223486

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LZO 2023-05-19

Exactech® Alteon® Short Tapered Wedge

Applicant Exactech, Inc.

K-Number K221323

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QNP 2023-05-19

GI Genius System 100 and GI Genius System 200

Applicant Cosmo Artificial Intelligence - Ai, Ltd.

K-Number K231143

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ODP 2023-05-19

Ventana™ C Spinal System

Applicant Spinal Elements, Inc.

K-Number K222833

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MXD 2023-05-19

BIOMONITOR IV

Applicant Biotronik, Inc.

K-Number K230375

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QJI 2023-05-19

iLet® Dosing Decision Software

Applicant Beta Bionics, Inc.

K-Number K220916

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