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

IMJ 2025-06-25

Curapuls 670

Applicant Enraf-Nonius, B.V.

K-Number K243112

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EBI 2025-06-25

Flexible Partial Resin

Applicant Prismatik Dentalcraft, Inc.

K-Number K250302

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BSP 2025-06-25

SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture

Applicant PAJUNK GmbH Medizintechnologie

K-Number K250774

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KGN 2025-06-25

GeniPhys Collymer Self-Assembling Scaffold

Applicant Geniphys, Inc.

K-Number K250329

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ITI 2025-06-25

Power Wheelchair (D26)

Applicant Anhui Jbh Medical Apparatus Co., Ltd.

K-Number K251606

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PBF 2025-06-25

CORIOGRAPH Pre-Op Planning and Modeling Services

Applicant Blue Belt Technologies, Inc.

K-Number K250921

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MBI 2025-06-25

BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

Applicant Smith & Nephew, Inc.

K-Number K251627

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GKZ 2025-06-25

Sysmex XR-Series (XR-20) Automated Hematology Analyzer

Applicant Sysmex America, Inc.

K-Number K251371

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BTT 2025-06-25

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K251611

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DQK 2025-06-25

Globe® Pulsed Field System

Applicant Kardium, Inc.

K-Number K250747

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DQY 2025-06-25

SAT CenterFlow Molding Balloon Catheter (IN20-00313)

Applicant Strait Access Technologies Holdings

K-Number K243184

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HTY 2025-06-24

PediFlex Flexible Nail System

Applicant OrthoPediatrics Corp.

K-Number K251362

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