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

NRY 2023-09-20

Socrates Aspiration System

Applicant Scientia Vascular, Inc.

K-Number K223913

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CGA 2023-09-20

Cholestech LDX ™ System

Applicant Alere San Diego, Inc.

K-Number K223179

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FMI 2023-09-20

Insulin Pen Needle

Applicant Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K-Number K230043

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LPH 2023-09-20

Mpact Extension

Applicant Medacta International S.A.

K-Number K230011

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PLP 2023-09-20

TULSA-PRO System

Applicant Profound Medical, Inc.

K-Number K230692

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HIF 2023-09-20

AirSeal iFS System; AirSeal dV Solution

Applicant Conmed Corporation

K-Number K230239

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OWN 2023-09-20

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM

Applicant Stryker

K-Number K231854

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LPH 2023-09-20

DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System

Applicant Depuy Ireland UC

K-Number K232556

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GEX 2023-09-20

LED Spectrum therapy instrument

Applicant Shenzhenshi Sincoheren S&T Development Co., Ltd.

K-Number K231894

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PHX 2023-09-20

Catalyst R1 Reverse Shoulder System

Applicant Catalyst Orthoscience, Inc.

K-Number K232583

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MBI 2023-09-20

CITRELOCK® DUO

Applicant Acuitive Technologies, Inc.

K-Number K232592

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MXJ 2023-09-20

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls

Applicant Biokit, S.A.

K-Number K213987

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