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

LLZ 2021-05-04

SOTA Cloud Imaging

Applicant Sota Precision Optics, Inc. Dba Sota Imaging

K-Number K210682

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FAJ 2021-05-04

Uro-G Cystoscope

Applicant Uroviu Corporation

K-Number K202921

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HTY 2021-05-04

CoLink Sfx Implant System

Applicant In2bones USA, LLC

K-Number K203698

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HGX 2021-05-04

Electric Breast Pump

Applicant Guangdong Horigen Mother & Baby Products Co., Ltd.

K-Number K201152

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EOX 2021-05-04

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)

Applicant Capnostics, LLC

K-Number K203450

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MQV 2021-05-04

CaP Spheres Pellet Pack

Applicant Zimmer Biomet Spine, Inc.

K-Number K203218

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FXX 2021-05-04

Surgical Mask

Applicant Jin Pin Electrical Co., Ltd. Zhuhai S.E.Z.

K-Number K210304

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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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