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

ODP 2022-08-26

HAcancellous PEEK-C Porous HA PEEK Cervical IBF System

Applicant Innovasis, Inc.

K-Number K220875

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OBP 2022-08-26

BrainsWay Deep TMS System

Applicant Brainsway , Ltd.

K-Number K220819

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GXN 2022-08-26

MedCAD AccuShape Titanium Patient-Specific Cranial Implant

Applicant Medcad

K-Number K220357

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MAI 2022-08-26

Arthrex Self Punching SwiveLock Suture Anchors

Applicant Arthrex, Inc.

K-Number K222263

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OXC 2022-08-26

NEOVEIL Staple Line Reinforcement

Applicant Gunze Limited

K-Number K221487

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GEI 2022-08-26

Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer

Applicant Conmed Corporation

K-Number K214058

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FTL 2022-08-26

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

Applicant Xiros, Ltd.

K-Number K220091

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MAX 2022-08-25

CONDUIT Lateral Switch Plate

Applicant Medos International SARL

K-Number K221325

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MUJ 2022-08-25

MRI Planner

Applicant Spectronic Medical AB

K-Number K211841

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NBW 2022-08-25

GlucoSure Link Blood Glucose Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K212140

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KTT 2022-08-25

ONX Large External Fixation System

Applicant Orthonovis, Inc.

K-Number K213905

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LYZ 2022-08-25

Disposable, vinyl examination gloves, Yellow

Applicant Dezhou Hengchang Medical Technology Co., Ltd.

K-Number K220055

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