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

FAJ 2023-09-29

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet

Applicant OTU Medical, Inc.

K-Number K231702

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DQY 2023-09-29

Amulet Steerable Delivery Sheath

Applicant ABBOTT MEDICAL

K-Number K232690

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QAT 2023-09-29

TBI

Applicant Abbott Laboratories

K-Number K232669

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QEI 2023-09-29

Miris Human Milk Analyzer (HMA)

Applicant Miris AB

K-Number K223085

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OHV 2023-09-29

BeShape One Device

Applicant Beshape Technologies , Ltd.

K-Number K231628

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QOI 2023-09-29

SafeBreak® Vascular

Applicant Lineus Medical

K-Number K231957

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DRF 2023-09-29

BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter

Applicant Boston Scientific Corporation

K-Number K232651

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JPA 2023-09-29

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM

Applicant Instrumentation Laboratory CO

K-Number K221359

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QYD 2023-09-29

Procise ADL

Applicant Procisedx, Inc.

K-Number DEN220023

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NKB 2023-09-29

KHEIRON® Spinal Fixation System, including patient specific K-ROD

Applicant S.M.A.I.O

K-Number K232650

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JKA 2023-09-28

PIVO Pro Needle-free Blood Collection Device

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K230865

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EMA 2023-09-28

BeautiLink SA

Applicant Shofu Dental Corporation

K-Number K233161

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