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

JOJ 2025-12-23

SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)

Applicant Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

K-Number K251991

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DZI 2025-12-23

VarioSurg 4

Applicant Nakanishi, Inc.

K-Number K254163

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DHB 2025-12-23

NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)

Applicant Hycor Biomedical

K-Number K252493

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MBH 2025-12-23

Active-V Total Knee System; World Total Knee System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K253239

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HRX 2025-12-23

MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

Applicant Medimaging Integrated Solution, Inc (Miis)

K-Number K253217

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NGL 2025-12-23

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

Applicant Healgen Scientific,, LLC

K-Number K253567

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NUH 2025-12-23

VEINOPLUS Back

Applicant Dynapulse Medical

K-Number K251958

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NHA 2025-12-23

Custom Abutments AS

Applicant Medentika GmbH

K-Number K253341

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NUH 2025-12-23

TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

Applicant Hong Qiangxing (Shenzhen) Electronics Limited

K-Number K253740

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DZE 2025-12-23

NizPlant Dental Implant System

Applicant Paragon Implant Mfg., LLC

K-Number K250476

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PZO 2025-12-23

Sim&Size

Applicant Sim&Cure

K-Number K253122

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NHA 2025-12-23

OrangeCAD Med Abutments

Applicant Orangecad Med GmbH

K-Number K253312

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