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

ETD 2024-02-16

Biowy Tym Tube (TT)

Applicant Biowy Corporation

K-Number K233658

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DYB 2024-02-16

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)

Applicant Synaptic Medical Corporation

K-Number K233708

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OWB 2024-02-16

Zenition 30

Applicant Philips Medical Systems Nederland B.V.

K-Number K232420

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CAH 2024-02-15

Breathing circuit bacterial/viral filter

Applicant Shaoxing Haitech Medical Products Co., Ltd.

K-Number K222917

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FGE 2024-02-15

VedDilator ^TM (3-Stage Balloon Dilation Catheter)

Applicant Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K-Number K232245

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LPH 2024-02-15

EMPHASYS™ Dual Mobility System

Applicant Depuy Ireland UC

K-Number K231522

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POS 2024-02-15

EpiMonitor

Applicant Empatica S.r.l.

K-Number K232915

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LXM 2024-02-15

SONIK MONARK 100

Applicant Neuro Spinal Innovation, Inc.

K-Number K234036

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IYN 2024-02-15

MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)

Applicant Medisono

K-Number K231659

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MOS 2024-02-15

Contour Shoulder

Applicant Quality Electrodynamics

K-Number K233656

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QZX 2024-02-15

PBC Separator with Selux AST System

Applicant Selux Diagnostics, Inc.

K-Number K223493

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PGY 2024-02-15

Medical Monitor (21HQ613D)

Applicant Lg Electronics.Inc

K-Number K240130

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