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

FXX 2021-04-23

Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs

Applicant String King Lacrosse, LLC

K-Number K202607

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HGI 2021-04-23

IRIS Thermocoagulator and Digital Colposcope

Applicant Liger Medical, LLC

K-Number K202915

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INI 2021-04-23

Solax Electric Scooter

Applicant Dongguan Prestige Sporting Goods Co., Ltd.

K-Number K192190

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NRY 2021-04-23

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

Applicant Imperative Care, Inc.

K-Number K210996

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NXC 2021-04-23

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)

Applicant 3M Company, Unitek Orthodontic Products

K-Number K211190

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KPS 2021-04-23

Cartesion Prime (PCD-1000A/3) V10.8

Applicant Canon Medical Systems Corporation

K-Number K203314

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PPN 2021-04-22

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter

Applicant Shockwave Medical, Inc.

K-Number K203365

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DZE 2021-04-22

IDCAM Dental Implants

Applicant Implants Diffusion International

K-Number K200329

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HGX 2021-04-22

Mya Joy PLUS Breast Pump

Applicant Ameda, Inc.

K-Number K203570

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LXC 2021-04-22

MY01 Continuous Compartmental Pressure Monitor

Applicant MY01, Inc.

K-Number K210525

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JOW 2021-04-22

DVT-PRO

Applicant Daesung Maref Co., Ltd.

K-Number K203353

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BZR 2021-04-22

Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50

Applicant Parker Hannifin

K-Number K202480

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