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

KKX 2023-10-25

BeneHold™ Surgical Incise Drape with CHG antimicrobial II

Applicant Avery Dennison Medical , Ltd.

K-Number K230645

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QNL 2023-10-25

SignalHF (IM008)

Applicant Implicity, Inc.

K-Number K230842

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OBP 2023-10-25

Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro

Applicant The Magstim Company , Ltd.

K-Number K232235

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KNS 2023-10-25

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)

Applicant Starmed Co., Ltd.

K-Number K233113

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IYO 2023-10-25

K3900 Ultrasound Imaging System

Applicant Maui Imaging

K-Number K230511

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NKB 2023-10-25

PERLA® TL Posterior Thoraco-lumbar Fixation System

Applicant Spineart SA

K-Number K231069

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MBI 2023-10-24

Knotilus+ PEEK Knotless Anchor

Applicant Stryker Endoscopy

K-Number K232683

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NKB 2023-10-24

Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System

Applicant K&J Consulting Corp.

K-Number K232586

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OAP 2023-10-24

Laser Cap, Model: Hat-01

Applicant Hubei Yjt Technology Co.,Ltd

K-Number K232356

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GEI 2023-10-24

PlaDuo System

Applicant ShenB Co., Ltd.

K-Number K232223

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HQF 2023-10-24

VISULAS green

Applicant Carl Zeiss Meditec

K-Number K232051

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GEI 2023-10-24

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System

Applicant C2dx, Inc.

K-Number K233185

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