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

LPL 2024-12-17

VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens

Applicant Vizionfocus, Inc.

K-Number K242413

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MID 2024-12-17

Aptiva APS IgG Reagent; Aptiva APS IgM Reagent

Applicant Inova Diagnostics, Inc.

K-Number K223093

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LZA 2024-12-17

Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

Applicant O&M Halyard, Inc.

K-Number K242558

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NUH 2024-12-17

POCKET TENS (EP-300)

Applicant Hivox Biotek, Inc.

K-Number K242815

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GEX 2024-12-17

Thulium Fiber Laser (FiberLAZE+, FiberLAZE)

Applicant Allengers Global Healthcare Private Limited

K-Number K242987

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NKB 2024-12-17

Reform Pedicle Screw System

Applicant Precision Spine, Inc.

K-Number K242297

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NHA 2024-12-17

ALLONUS Tech Prosthetics

Applicant Allonus Tech Co., Ltd.

K-Number K241616

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DPS 2024-12-17

Cardiac Workstation (5000); Cardiac Workstation (7000)

Applicant Philips Medizin Systeme Böblingen GmbH

K-Number K241556

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KRD 2024-12-16

TEMBO Embolic System

Applicant Instylla, Inc.

K-Number K240873

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CCK 2024-12-16

AIM (N/A)

Applicant Inventeur, LLC

K-Number K240937

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JXG 2024-12-16

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set

Applicant Aesculap, Inc.

K-Number K242003

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FRO 2024-12-16

LUOFUCON® Silver Collagen Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K240809

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