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

MQV 2022-04-14

MagnetOs Flex Matrix

Applicant Kuros Biosciences B.V

K-Number K213959

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LON 2022-04-14

VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)

Applicant bioMerieux, Inc.

K-Number K214023

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LLZ 2022-04-14

TeleScan

Applicant Bb Imaging

K-Number K220767

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NHA 2022-04-14

High Retention Attachment System

Applicant Zest Anchors, LLC

K-Number K220252

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DPS 2022-04-14

Coala Heart Monitor

Applicant Coala Life AB

K-Number K212163

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LZA 2022-04-14

Disposable Medical Nitrile Examination Gloves

Applicant Nanjing Universal Medical Equipment Co., Ltd.

K-Number K220561

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MQB 2022-04-14

Yushan X-Ray Flat Panel Detector with DROC

Applicant Innocare Optoelectronics Corp.

K-Number K220510

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JOW 2022-04-14

Amputee Garment for use with Lympha Press Optimal Plus

Applicant Mego Afek AC , Ltd.

K-Number K214053

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FGE 2022-04-13

BIOTEQ Drainage Catheter BT-PDS-series

Applicant Bioteque Corporation

K-Number K210419

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QJP 2022-04-13

Bendit21 Microcatheter

Applicant Bend IT Technologies, Ltd.

K-Number K203842

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MHX 2022-04-13

Carescape B850, E-musb

Applicant GE Healthcare Finland Oy

K-Number K213336

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NUC 2022-04-13

Sensuva Premium Silicone Personal Lubricant

Applicant Valencia Naturals, Inc.

K-Number K212260

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