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

LLZ 2023-12-12

TeleScan

Applicant Bb Imaging

K-Number K233634

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GEI 2023-12-12

SIRA™ RFA Electrosurgical Device

Applicant Innoblative Designs, Inc.

K-Number K232947

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OWB 2023-12-12

Ziehm Solo FD

Applicant Ziehm Imaging GmbH

K-Number K231669

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DYB 2023-12-12

Intri24 Introducer Sheath (52-101)

Applicant Inari Medical, Inc.

K-Number K233646

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QIH 2023-12-11

Transpara Density 1.0.0

Applicant Screenpoint Medical B.V.

K-Number K232096

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FXX 2023-12-11

Hygenix

Applicant Shenzhen Hygenix Industrial Co., Ltd.

K-Number K232797

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GEI 2023-12-11

INTELLIO SHIFT System

Applicant ArthroCare Corporation

K-Number K232290

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PGY 2023-12-11

24HR513C

Applicant Lg Electronics.Inc

K-Number K232985

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MBH 2023-12-11

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology

Applicant Depuy Ireland UC

K-Number K232303

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DHA 2023-12-11

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

Applicant Shenzhen Yhlo Biotech Co., Ltd.

K-Number K223690

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DXN 2023-12-11

Wrist Blood Pressure Monitor

Applicant Zhuhai Yueja Medical Device Technology Co., Ltd.

K-Number K232815

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DRA 2023-12-11

FARADRIVE™ Steerable Sheath

Applicant Boston Scientific Corporation

K-Number K233248

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