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

MAX 2024-12-06

DZ-Tabone Intervertebral Body Fusion Device

Applicant Shenzhen Dazhou Medical Technology Co., Ltd.

K-Number K241073

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NUC 2024-12-06

INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant

Applicant Project Chemistry, Inc.

K-Number K242645

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FDS 2024-12-06

PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)

Applicant Pentax of America, Inc.

K-Number K241213

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LLZ 2024-12-05

Rapid Surgical Plan (RSP-SW-001)

Applicant Navbit Pty, Ltd.

K-Number K243447

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KOI 2024-12-05

iTOF®

Applicant Nerbio Medical Software Platforms, Inc.

K-Number K242525

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NHA 2024-12-05

LW Pre-milled Abutment

Applicant Ossvis Co., Ltd.

K-Number K242703

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EIH 2024-12-05

Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)

Applicant Liaoning Rachcera Material Technology Co., Ltd.

K-Number K242740

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DQK 2024-12-05

Magnetic Localization Patch Kit (AFR-00021)

Applicant Medtronic, Inc.

K-Number K243435

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LZO 2024-12-05

BIOCERAM AZUL® HEAD

Applicant Kyocera Corporation

K-Number K243444

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MQV 2024-12-05

MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

Applicant Orthocon, Inc.

K-Number K243526

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HRS 2024-12-05

TDM Plate and Screw System

Applicant Tdm Co., Ltd.

K-Number K241128

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LOD 2024-12-05

OSTEOPAL® V

Applicant Heraeus Medical GmbH

K-Number K241674

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