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

OMP 2023-03-23

3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)

Applicant 3M

K-Number K222859

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GEI 2023-03-23

ClosureFast™ Endovenous Radiofrequency Ablation Catheter

Applicant Medtronic, Inc.

K-Number K223488

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FMF 2023-03-23

Sterile Hypodermic Syringe for Single Use

Applicant Shandong Weigao Group Medical Polymer Co., Ltd.

K-Number K212207

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DQD 2023-03-23

AccurSound Electronic Stethoscope AS-101

Applicant Heroic Faith International , Ltd.

K-Number K221805

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NKB 2023-03-23

Swedge™ Pedicle Screw Fixation System

Applicant Spinal Resources, Inc.

K-Number K230482

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MBI 2023-03-23

Fixone All Suture Anchor

Applicant Aju Pharm Co., Ltd.

K-Number K222423

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FRG 2023-03-23

Sterilization Wrap

Applicant Kenpax International Limited

K-Number K222151

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DZL 2023-03-23

SAVE GBR

Applicant Dentis Co., Ltd.

K-Number K222367

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KWY 2023-03-23

SpaceFlex Acetabular Cup

Applicant G21, S.R.L.

K-Number K223441

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DRA 2023-03-22

POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor

Applicant Boston Scientific Corporation

K-Number K223824

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GXY 2023-03-22

Motive™ Electrode

Applicant Cymedica Orthopedics, Inc.

K-Number K230533

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ODP 2023-03-22

Tryptik Ti

Applicant Spineart SA

K-Number K230583

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