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

LZA 2022-04-11

Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black

Applicant Aamedix Glove Sdn Bhd

K-Number K220121

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KRA 2022-04-11

Micro Catheter and Guidewire System

Applicant Suzhou Hengrui Hongyuan Medical Co., Ltd.

K-Number K212719

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OWN 2022-04-11

Cellvizio 100 series system with confocal Miniprobes

Applicant Mauna Kea Technologies

K-Number K220477

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DQY 2022-04-11

XO CROSS CORONARY Support Catheter

Applicant Transit Scientific, LLC

K-Number K214107

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LZA 2022-04-09

Nitrile Examination Gloves

Applicant Watchtower Ppe Supplies, Inc.

K-Number K212929

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LZA 2022-04-09

Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim

Applicant Riverstone Resources Sdn Bhd

K-Number K220401

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KTT 2022-04-08

Drive Rail System

Applicant OrthoPediatrics Corp.

K-Number K220809

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QDB 2022-04-08

Fitbit Irregular Rhythm Notifications

Applicant Fitbit, Inc.

K-Number K212372

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MUJ 2022-04-08

INT Contour

Applicant Carina Medical, LLC

K-Number K212274

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GAG 2022-04-08

ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler

Applicant Ethicon Endo-Surgery, LLC

K-Number K213633

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MOS 2022-04-08

Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T

Applicant Noras Mri Products GmbH

K-Number K220144

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NKB 2022-04-08

CD Horizon™ Spinal System and PASS LP™ Spinal System

Applicant Medicrea International

K-Number K220724

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