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

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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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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OUR 2023-09-28

Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System

Applicant Lesspine Innovations

K-Number K232605

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QBD 2023-09-28

DNA/RNA Shield SafeCollect Saliva Collection kit

Applicant Zymo Research

K-Number K231013

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