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

DQY 2022-07-29

091 Balloon Guide Catheter

Applicant Inneuroco, Inc.

K-Number K220331

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EGS 2022-07-29

Dental Handpiece, Model CA160, CA160L, and CA500L

Applicant Micro-Nx Co., Ltd.

K-Number K220577

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GEI 2022-07-28

Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm

Applicant Conmed Corporation

K-Number K221945

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MWJ 2022-07-28

Biotres

Applicant Biotricity

K-Number K222017

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LNH 2022-07-28

Swoop Portable MR Imaging System

Applicant Hyperfine, Inc.

K-Number K221923

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NKB 2022-07-28

INERTIA CONNEXX Modular Pedicle Screw System

Applicant Nexxt Spine, LLC

K-Number K221905

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OWB 2022-07-28

Trinias

Applicant Shimadzu Corporation Medical Systems Division

K-Number K221922

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OWB 2022-07-28

TRON

Applicant Xoran Technologies, LLC

K-Number K221230

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FDX 2022-07-28

Single Use Cytology Brush

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K220063

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QIH 2022-07-28

cvi42 Auto Imaging Software Application

Applicant Circle Cardiovascular Imaging, Inc.

K-Number K213998

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KNT 2022-07-28

Gastrointestinal Boundary Identifier (GIBI HD)

Applicant Reshape Lifesciences

K-Number K221898

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NKB 2022-07-28

OsteoCentric Spine MIS Pedicle Fastener System

Applicant OsteoCentric Technologies

K-Number K221332

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