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

FGB 2023-05-18

Single-Use Flexible Ureteroscope

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K230200

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OBJ 2023-05-18

OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter

Applicant Boston Scientific Corporation

K-Number K230453

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GZL 2023-05-18

Anchor Bolts as Accessories to Depth Electrodes

Applicant Ad-Tech Medical Instrument Corporation

K-Number K223276

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FPA 2023-05-18

I.V. Administration Set, I.V. Extension Set

Applicant Bq Plus Medical Co., Ltd.

K-Number K223645

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GEI 2023-05-18

Single Use Bipolar Forceps

Applicant Hg Innovations, Ltd.

K-Number K230432

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GZL 2023-05-18

Spencer Probe Depth Electrodes

Applicant Ad-Tech Medical Instrument Corporation

K-Number K223269

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MBI 2023-05-18

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K231113

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QSZ 2023-05-18

Restrata® MiniMatrix

Applicant Acera Surgical, Inc.

K-Number K223725

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KKX 2023-05-18

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

Applicant 3M Company

K-Number K222578

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EKX 2023-05-18

Endo Motor

Applicant Foshan Coxo Medical Instrument Co., Ltd.

K-Number K220829

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JWY 2023-05-18

ComASP Cefiderocol 0.008-128

Applicant Liofilchem s.r.l.

K-Number K230479

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GEH 2023-05-18

Claritag Advanced

Applicant Dgi Technologies

K-Number K222356

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