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

NHI 2021-12-20

First Relief

Applicant Dyansys, Inc.

K-Number K212859

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LYZ 2021-12-20

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Applicant Liao Ning Shangwei Medical Products Co., Ltd.

K-Number K211865

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JWY 2021-12-20

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml

Applicant Thermo Fisher Scientific

K-Number K203741

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DXC 2021-12-20

TR BAND Radial Compression Device

Applicant Terumo Medical Corporation

K-Number K213531

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OTM 2021-12-20

AdVance XP Male Sling System

Applicant Boston Scientific Corporation

K-Number K211847

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QIH 2021-12-20

EchoGo Core (2.0)

Applicant Ultromics Limited

K-Number K213275

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ODP 2021-12-20

Vy Spine ClariVy Cervical IBF System

Applicant Vy Spine, LLC

K-Number K212715

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NLG 2021-12-20

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

Applicant Innovative Health, LLC

K-Number K212776

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LZC 2021-12-20

AspenMed+

Applicant Aspen Glove Sdn. Bhd.

K-Number K213076

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KCT 2021-12-20

TCAT TKA Instrument Tray

Applicant THINK Surgical, Inc.

K-Number K203468

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OAT 2021-12-19

ATOZ Mini-Screw

Applicant Mk Meditech, Inc.

K-Number K210559

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LZA 2021-12-18

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)

Applicant Huayuan Medical Technology(Shangqiu) Co., Ltd.

K-Number K213048

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