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

LNH 2021-11-24

AMRA Profiler

Applicant Amra Medical AB

K-Number K211983

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QAI 2021-11-24

MicroPen EVO

Applicant Eclipse Medcorp, LLC

K-Number K212558

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OWB 2021-11-24

ControlRad Select Model Z

Applicant Controlrad, Inc.

K-Number K213455

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JFY 2021-11-24

Atellica CH Enzymatic Creatinine_3 (ECre3)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K212223

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EOQ 2021-11-24

Bronchoscope System

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K211169

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FLL 2021-11-24

Non-Contact Infrared Thermometer, model HL710H

Applicant Health & Life Co., Ltd.

K-Number K211744

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HRS 2021-11-24

Xpert Wrist

Applicant Newclip Technics

K-Number K213214

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QMY 2021-11-24

Regulora

Applicant Metame Health, Inc.

K-Number K211463

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EBF 2021-11-24

C-30 Crown Kit

Applicant Perfect Fit Crowns, LLC

K-Number K211345

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KTI 2021-11-24

Trachealator

Applicant Disa Medinotec

K-Number K211894

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FXX 2021-11-24

Surgical Mask (sterile)

Applicant Nanjing 3h Medical Products Co., Ltd.

K-Number K211295

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FYC 2021-11-24

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue

Applicant String King Lacrosse, LLC

K-Number K212633

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