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

BTA 2021-05-04

Medline Vacu-line Suction Aspirator

Applicant Medline Industries, Inc.

K-Number K203135

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DTX 2021-05-04

Quantum Mini Ventilation Module

Applicant Spectrum Medical , Ltd.

K-Number K210669

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LHI 2021-05-04

ProntoPump Sterile Tube Set

Applicant Ipax, Inc.

K-Number K200893

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NLH 2021-05-04

Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)

Applicant Innovative Health, LLC

K-Number K203655

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HAE 2021-05-04

Rebellion, Phantom Multi-Bite Kerrison Rongeur

Applicant Morpheus AG

K-Number K200768

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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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