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

JSM 2025-04-04

AllTest Viral Transport Medium

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K242576

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KPO 2025-04-04

Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K243786

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LIT 2025-04-04

Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Applicant Biotronik, Inc.

K-Number K250706

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FRG 2025-04-04

Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)

Applicant Turbett Surgical

K-Number K250011

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FMI 2025-04-04

K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)

Applicant Terumo Europe N.V.

K-Number K243581

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PTC 2025-04-04

UASure II Blood Uric Acid Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K242209

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MAX 2025-04-04

Spectrum Spine Lumbar Cage System

Applicant Spectrum Spine, Inc.

K-Number K243074

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BTL 2025-04-04

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)

Applicant Draegerwerk AG & CO Kgaa

K-Number K242769

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QEZ 2025-04-04

JETi Hydrodynamic Thrombectomy System

Applicant ABBOTT MEDICAL

K-Number K243549

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QHA 2025-04-04

QFR (3.0)

Applicant Qfr Solutions BV

K-Number K243769

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QIH 2025-04-03

syngo Dynamics (Version VA41D)

Applicant Siemens Healthcare GmbH

K-Number K242551

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IYN 2025-04-03

Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System

Applicant Carbon (Shenzhen) Medical Device Co., Ltd.

K-Number K243298

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