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

NKB 2024-11-05

CarboClear® Hybrid Pedicle Screw System

Applicant CarboFix Orthopedics , Ltd.

K-Number K243106

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GEI 2024-11-05

POTENZA

Applicant Jeisys Medical, Inc.

K-Number K231287

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KWQ 2024-11-05

Skyway Anterior Cervical Plate System

Applicant Kyocera Medical Technologies, Inc.

K-Number K243015

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IZQ 2024-11-05

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

Applicant Imaxeon Pty, Ltd.

K-Number K241849

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MCW 2024-11-05

FreedomFlow™ Orbital Circumferential Atherectomy System

Applicant Cardio Flow Inc.,

K-Number K242947

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HSB 2024-11-05

Atlas™ Humeral Nail System

Applicant Orthopedic Designs North America, Inc. (Odi-Na)

K-Number K241484

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QIH 2024-11-05

TeraRecon Cardiac.Chambers.MR (1.0.0)

Applicant Terarecon,Inc.

K-Number K241312

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GWF 2024-11-05

Delphi Stimulator

Applicant Quantalx Neuroscience

K-Number K242345

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FMK 2024-11-05

gentleheel® Adult Incision Device

Applicant Gri-Alleset, Inc.

K-Number K242664

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LLZ 2024-11-04

JLK-PWI

Applicant JLK, Inc.

K-Number K242709

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ORZ 2024-11-04

Tixel i (TXLI0001)

Applicant Novoxel , Ltd.

K-Number K240512

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FRG 2024-11-04

CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)

Applicant Comercializadora Brever

K-Number K240438

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