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

FMI 2023-11-27

SteriCap Safety Needle; VitreJect Safety Needle

Applicant Ocuject, LLC

K-Number K233343

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NVK 2023-11-27

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)

Applicant Medency S.R.L.

K-Number K232222

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NKG 2023-11-27

Statera-C™ Spinal System

Applicant K&J Consulting Corp.

K-Number K233332

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DQK 2023-11-25

NeuTrace EP Mapping System v.2.1

Applicant Anumana, Inc.

K-Number K233160

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IPF 2023-11-24

Stim2Go

Applicant PAJUNK GmbH Medizintechnologie

K-Number K230701

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GAT 2023-11-24

HyperSuture

Applicant Threadstone, LLC

K-Number K230311

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PNG 2023-11-24

Passio Pump Drainage System

Applicant Bearpac Medical

K-Number K230319

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ETD 2023-11-24

Tympanostomy Tubes

Applicant Grace Medical, Inc.

K-Number K232059

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NFO 2023-11-24

MF SC Facial Toning System

Applicant Micro Current Technology, Inc.

K-Number K233525

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DSH 2023-11-22

Carnation Ambulatory Monitor

Applicant Bardy Diagnostics, Inc.

K-Number K233110

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GEH 2023-11-22

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)

Applicant Boston Scientific

K-Number K232635

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ODC 2023-11-22

Disposable Endoscope Valves Kit

Applicant Shanghai SeeGen Photoelectric Technology Co., Ltd.

K-Number K222499

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