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

GEX 2022-07-14

Alma Diode Tabletop Laser

Applicant Alma Lasers , Ltd.

K-Number K212073

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FMF 2022-07-14

Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K-Number K220204

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OMP 2022-07-14

Dermatac Drape

Applicant 3M

K-Number K220560

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LYY 2022-07-14

Examination gloves-Type A(Latex gloves)

Applicant Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

K-Number K214017

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OLO 2022-07-14

Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V

Applicant Remex Medical Corporation

K-Number K220348

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QNV 2022-07-14

AHI System

Applicant Fifth Eye, Inc.

K-Number K221203

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NHA 2022-07-14

TruAbutment DS, TruBase

Applicant Truabutment, Inc.

K-Number K213961

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HCG 2022-07-14

CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems

Applicant Medos International SARL

K-Number K220040

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OLO 2022-07-14

E-GPS Navigated Instruments

Applicant Precision Spine, Inc.

K-Number K220862

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KGN 2022-07-14

PELNAC Meshed Bilayer Wound Matrix

Applicant Gunze Limited

K-Number K213498

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IRP 2022-07-14

Normatec Go

Applicant NormaTec Industries, LP

K-Number K221666

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NXC 2022-07-14

SmileSeries

Applicant Ordont Orthodontic Laboratories, Inc.

K-Number K221097

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