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

HAW 2024-01-12

SmartFrame OR

Applicant ClearPoint Neuro, Inc.

K-Number K233141

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OHS 2024-01-12

LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)

Applicant Shenzhen Idea Light Limited

K-Number K233114

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EIH 2024-01-12

Zirconia Block

Applicant Hangzhou Ivista Medical Devices Co., Ltd.

K-Number K233125

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NHA 2024-01-12

Ti Link Abutment

Applicant Izenimplant Co., Ltd.

K-Number K232170

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HIF 2024-01-12

TauTona Pneumoperitoneum Assist Device (TPAD)

Applicant Tautona Group Research & Development, Co., LLC

K-Number K233020

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NEU 2024-01-12

LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape))

Applicant Devicor Medical Products, Inc.

K-Number K232615

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LZA 2024-01-12

Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

Applicant Anhui Powerguard Technology Co., Ltd.

K-Number K233520

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HAW 2024-01-12

ClearPoint Bone Screw Fiducials

Applicant ClearPoint Neuro, Inc.

K-Number K233144

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HAW 2024-01-12

ClearPointer Optical Navigation Wand

Applicant ClearPoint Neuro, Inc.

K-Number K233155

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FZP 2024-01-12

Hem-o-lok® Ligating Clips

Applicant Teleflex Medical

K-Number K232970

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QWO 2024-01-12

Fibresolve

Applicant Imvaria, Inc.

K-Number DEN220040

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PBZ 2024-01-11

SurgiCount+ System

Applicant Stryker Instruments

K-Number K232250

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