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

KCT 2022-12-30

Aesculap AICON Container

Applicant Aesculap, Inc.

K-Number K214041

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DRF 2022-12-30

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter

Applicant Shanghai Microport EP Medtech Co., Ltd.

K-Number K210313

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LLZ 2022-12-30

Cyware 4H and Cysart 4H

Applicant Abys Medical

K-Number K221796

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LLZ 2022-12-30

PeekMed web (v1)

Applicant Peek Health, S.A.

K-Number K222767

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DQA 2022-12-30

Fingertip Pulse Oximeter

Applicant Shenzhen Witleaf Medical Electronics Co., Ltd.

K-Number K213430

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LRK 2022-12-30

DNA Appliance

Applicant Vivos Therapeutics, Inc.

K-Number K222872

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LYC 2022-12-30

CMFlexTM

Applicant Dimension Inx Corp.

K-Number K213260

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DQA 2022-12-30

Biobeat Platform-2 and BB-613WP Patch

Applicant Biobeat Technologies , Ltd.

K-Number K222010

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LLZ 2022-12-30

aprevo® Digital Workflow

Applicant Carlsmed, Inc.

K-Number K222195

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MQB 2022-12-30

X-ray Flat Panel Detectors (EverestView 4343X)

Applicant Careray Digital Medical Technology Co., Ltd.

K-Number K223687

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OMB 2022-12-30

Persyst 15 EEG Review and Analysis Software

Applicant Persyst Development Corporation

K-Number K222002

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OCL 2022-12-30

Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)

Applicant AtriCure, Inc.

K-Number K221358

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