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

LYY 2023-06-13

Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)

Applicant Kossan International Sdn Bhd

K-Number K230573

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SBF 2023-06-13

OptiVu™ ROSA® MxR

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K-Number K230567

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OWR 2023-06-13

Tisuthes e-PTFE Surgical Patch

Applicant Shanghai Suokang Medical Implants Co., Ltd.

K-Number K201153

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BZG 2023-06-12

SpiroHome Personal, SpiroHome Clinic

Applicant Inofab Saglik Teknolojileri A.S

K-Number K213754

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QEW 2023-06-12

Pounce™ Thrombectomy System

Applicant Surmodics,Inc.

K-Number K231022

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CIG 2023-06-12

Atellica® CH Diazo Direct Bilirubin (D_DBil)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K223078

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HWC 2023-06-12

Cut Screw - Percutaneous Compression Screw

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K230397

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NZP 2023-06-12

SecurePortIV Advanced Catheter Securement Adhesive

Applicant Adhezion Biomedical, LLC

K-Number K223669

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MSS 2023-06-12

RxSight Insertion Device

Applicant Rxsight, Inc.

K-Number K231466

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OMP 2023-06-12

Genadyne Hybrid Foam Dressings

Applicant Genadyne Biotechnologies, Inc.

K-Number K221888

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DTN 2023-06-10

BMR 1900 PHISIO

Applicant Sorin Group Italia S.R.L.

K-Number K223361

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HSB 2023-06-09

Gamma4 System

Applicant Stryker GmbH

K-Number K230512

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