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

DZE 2021-08-13

Neodent Implant System - Zirconia Implant System

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K210336

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DXN 2021-08-13

Caretaker Platform, VitalStream Platform, CT5

Applicant Caretaker Medical

K-Number K211588

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LZA 2021-08-13

Powder Free Nitrile Patient Examination Gloves, Blue Color

Applicant Anhui Powerguard Technology Co., Ltd.

K-Number K211860

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OMP 2021-08-13

Nisus Touch Negative Pressure Wound Therapy Pump

Applicant Cork Medical Products, LLC

K-Number K203693

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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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