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

DXN 2021-08-13

Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107

Applicant Weony (Shenzhen) Technology Co., Ltd.

K-Number K210671

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FPA 2021-08-13

Insignis Subcutaneous Needle Sets

Applicant Innovative Health Sciences, LLC

K-Number K202279

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DQY 2021-08-13

WATCHMAN FXD Curve Access System

Applicant Boston Scientific Corporation

K-Number K212228

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IZL 2021-08-13

NFLK-2501 Portable X-ray Unit

Applicant Neuf, Inc.

K-Number K211383

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OWB 2021-08-13

ARCO FP-S

Applicant A.T.S. Applicazione Tecnologie Speciali S.R.L.

K-Number K211777

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ITX 2021-08-13

EMM Ultrasonic Transducer Cover

Applicant Exact Medical Manufacturing

K-Number K211969

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CGA 2021-08-13

i-STAT CHEM8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K210958

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HEB 2021-08-13

Every Cycle Reusable Tampon Applicator

Applicant Cycle, LLC

K-Number K211519

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DLZ 2021-08-13

VITROS Chemistry Products PHBR Slides

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number K210858

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MXC 2021-08-13

Jot Dx Insertable Cardiac Monitor

Applicant Abbott (St. Jude Medical)

K-Number K212206

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GWF 2021-08-13

MEGA-TMS

Applicant Soterix Medical, Inc.

K-Number K192823

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HRS 2021-08-13

Tyber Medical Anatomical Plating System

Applicant Tyber Medical, LLC

K-Number K203817

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