Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

IZL 2017-11-20

MDR17 Mobile Direct Radiographic System

Applicant Del Medical, Inc.

K-Number K173018

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LCX 2017-11-20

LIA Pregnancy Test

Applicant Lia Diagnostics

K-Number K171136

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DTK 2017-11-20

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

Applicant William Cook Europe Aps

K-Number K172557

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HSX 2017-11-20

Materialise PKA Guide System

Applicant Materialise NV

K-Number K172650

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DTZ 2017-11-20

Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface

Applicant Medtronic, Inc.

K-Number K172984

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DXQ 2017-11-20

Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff

Applicant Ningbo Albert Novosino Co., Ltd.

K-Number K173044

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GEI 2017-11-20

ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length

Applicant Ethicon Endo-Surgery, LLC

K-Number K172580

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PLR 2017-11-20

Modulift Vertebral Body Replacement (VBR) System

Applicant Aesculap Implants Systems, Inc.

K-Number K172032

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EOQ 2017-11-20

B7 2C Occlusion Balloon

Applicant Spiration, Inc.

K-Number K171492

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MBI 2017-11-20

Stryker Self-Punching ICONIX

Applicant Stryker

K-Number K172921

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CBP 2017-11-17

Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)

Applicant Xiamen Compower Medical Tech. Co., Ltd.

K-Number K171961

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KCT 2017-11-17

SterilContainer with PrimeLine Pro Lid

Applicant Aesculap, Inc.

K-Number K172850

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