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

DGC 2024-05-31

Kenota 1 Total IgE; Kenota 1 (instrument)

Applicant Kenota, Inc.

K-Number K231151

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HRS 2024-05-31

Tyber Medical Anatomical Plating System

Applicant Tyber Medical, LLC

K-Number K241218

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LLZ 2024-05-31

Mimics Enlight CMF

Applicant Materialise NV

K-Number K223427

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OHT 2024-05-31

IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)

Applicant Shenzhen Semlamp Intelligent Technology Co., Ltd.

K-Number K240969

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QKQ 2024-05-30

aetherSlide

Applicant Aetherai Co., Ltd.

K-Number K233126

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OHV 2024-05-30

SofWave System

Applicant Sofwave Medical, Ltd.

K-Number K240687

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JWJ 2024-05-30

Freedom Wrist Arthroplasty System

Applicant Ascension Orthopedics, Inc.

K-Number K233674

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QOF 2024-05-30

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini

Applicant Biofire Diagnostics, LLC

K-Number K241194

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KRD 2024-05-30

Sunsphere

Applicant Hangzhou Yangshun Medical Technology Co.,Ltd

K-Number K232934

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KTT 2024-05-30

Revolution External Plating System

Applicant New Standard Device Dba Metalogix

K-Number K233025

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PMN 2024-05-30

SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control

Applicant Maine Molecular Quality Controls, Inc.

K-Number K241289

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ODP 2024-05-30

Spectrum Spine Cervical Cage System

Applicant Spectrum Spine, Inc.

K-Number K240838

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