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

JAK 2023-06-13

CAC Software

Applicant Imbio, Inc.

K-Number K230112

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QRK 2023-06-13

SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)

Applicant Bosungmeditech Co., Ltd.

K-Number K230759

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PNN 2023-06-13

iOrtho

Applicant Shanghai EA Medical Instruments Co., Ltd.

K-Number K223518

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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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