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

KGN 2024-08-21

Kerecis Parvus (50207)

Applicant Kerecis Limited

K-Number K241080

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GZF 2024-08-21

Nalu Neurostimulation System for Peripheral Nerve Stimulation

Applicant Boston Scientific Neuromodulation

K-Number K232415

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FRO 2024-08-21

Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo

Applicant Bionova Medical, Inc.

K-Number K240298

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MQV 2024-08-21

Montage-XT Settable, Resorbable Bone Putty

Applicant Orthocon, Inc.

K-Number K233566

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GEX 2024-08-21

Fraxel® FTX Laser System

Applicant Solta Medical

K-Number K242142

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DQX 2024-08-21

Glidewire GT-R

Applicant Terumo Corporation

K-Number K240859

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GWG 2024-08-21

cCeLL - In vivo

Applicant VPIX Medical, Inc.

K-Number K233391

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OMP 2024-08-21

VERSA Negative Pressure Wound Therapy System (VCMPP-100)

Applicant Cork Medical

K-Number K241061

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FMK 2024-08-20

MedtFine Safety Lancet

Applicant Ningbo Caremed Medical Products Co., Ltd.

K-Number K241848

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ODP 2024-08-20

PYXIS 3D Titanium Cervical Cage system

Applicant GS Medical Co., Ltd.

K-Number K241738

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JXG 2024-08-20

Borvo EVAC System (Ergo); Borvo EVAC System (Classic)

Applicant Borvo Medical, Inc.

K-Number K241458

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OCX 2024-08-20

ClearCap Distal Attachment

Applicant Finemedix Co., Ltd.

K-Number K242134

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