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

LLZ 2021-05-04

PtoleMedic System

Applicant Lento Medical Innovation, Inc.

K-Number K202521

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DQX 2021-05-04

VASSALLO GT Hybrid

Applicant Filmecc Co., Ltd.

K-Number K203529

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QKZ 2021-05-04

NaviCam Xpress Stomach System

Applicant Anx Robotica Corp

K-Number K203192

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OVD 2021-05-04

A-Link Z

Applicant Acuity Surgical Devices, LLC

K-Number K201671

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PZS 2021-05-03

MC3 Crescent Jugular Dual Lumen Catheter

Applicant Mc3, Inc.

K-Number K203409

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GAT 2021-05-03

EasyWhip

Applicant Winter Innovations, Inc.

K-Number K210675

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IPF 2021-05-03

Storz Medical MAGNETOLITH Muscle Stimulator

Applicant Storz Medical AG

K-Number K203710

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CBI 2021-05-03

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable

Applicant Ambu A/S

K-Number K203749

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KOI 2021-05-02

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series

Applicant Nihon Kohden Corporation

K-Number K201949

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OXH 2021-05-02

Kerecis Reconstruct

Applicant Kerecis Limited

K-Number K202430

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JDO 2021-04-30

OsteoCentric Integrated Hip Fastener System

Applicant Osteocentric Technologies D.B.A. Osteocentric Trauma

K-Number K210247

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OWW 2021-04-30

The BioBrace Implant

Applicant Biorez, Inc.

K-Number K203267

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