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

OLO 2023-09-08

Fusion Robotic Navigation System

Applicant Alphatec Spine, Inc.

K-Number K232413

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MBH 2023-09-08

Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts

Applicant Conformis, Inc.

K-Number K232426

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FMI 2023-09-08

Sterile syringes for single use with/without needle

Applicant Wepon Medical Technology Co., Ltd.

K-Number K231729

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OCW 2023-09-08

MaxTack™ Motorized Fixation Device

Applicant Covidien

K-Number K231240

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NQQ 2023-09-08

ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6

Applicant ABBOTT MEDICAL

K-Number K232386

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QXZ 2023-09-08

Cleerly ISCHEMIA

Applicant Cleerly, Inc.

K-Number K231335

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LZA 2023-09-08

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Applicant Syntex Healthcare Products Co., Ltd.

K-Number K231643

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QXX 2023-09-08

CorVista® System

Applicant Corvista Health, Inc.

K-Number K232686

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JWH 2023-09-08

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post

Applicant Total Joint Othopedics, Inc.

K-Number K232414

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QIH 2023-09-08

DeepXray

Applicant Alpha Intelligence Manifolds, Inc.

K-Number K223621

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MBI 2023-09-08

Q-FIX ULTRA All-Suture Anchor

Applicant Smith & Nephew

K-Number K232457

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FDF 2023-09-08

FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01

Applicant Fujifilm Corporation

K-Number K223827

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