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

QFT 2023-12-13

EndeavorRx

Applicant Akili Interactive Labs, Inc.

K-Number K231337

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LNH 2023-12-13

fMRI Hardware System

Applicant Nordicneurolab AS

K-Number K232680

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NHA 2023-12-13

Neodent Implant System - Zirconia Implant System

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K231803

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DKZ 2023-12-13

AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K233019

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OHS 2023-12-13

Radiant Renewal Skincare Wand (HD-15, HD-15A)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K232863

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QVF 2023-12-13

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

Applicant Quidel Corporation

K-Number K233688

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KGN 2023-12-13

MiroTract Wound Matrix

Applicant Reprise Biomedical, Inc.

K-Number K231614

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NDC 2023-12-12

Insulia Bolus Companion

Applicant Voluntis Sa.

K-Number K232451

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KCT 2023-12-12

Aygün Sterilization Container Systems

Applicant Aygun Surgical Instruments Co., Inc.

K-Number K233222

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FMI 2023-12-12

Sterile Hypodermic Needles for Single Use

Applicant Zhejiang Kindly Medical Device Co., Ltd.

K-Number K233037

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NKB 2023-12-12

TriALTIS Spine System

Applicant Medos International SARL

K-Number K233684

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QHE 2023-12-12

Signature ONE System

Applicant Orthosoft Inc. (D/B/A) Zimmer Cas)

K-Number K232425

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