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

PZO 2019-09-17

Sim&Size

Applicant Sim&Cure

K-Number K190049

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LZA 2019-09-16

Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim

Applicant Kossan International Sdn Bhd

K-Number K191800

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NKB 2019-09-16

Mercury® Spinal System, Overwatch® Spinal System

Applicant Spinal Elements, Inc.

K-Number K191576

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GEX 2019-09-16

PicoWay Laser System

Applicant Candela Corporation

K-Number K191685

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MAX 2019-09-16

AccelFix Lumbar Interbody Fusion Cage System

Applicant L&K BIOMED Co., Ltd.

K-Number K190708

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MUD 2019-09-16

Intra.Ox 2.0 Handheld Tissue Oximeter

Applicant Vioptix, Inc.

K-Number K191676

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DXN 2019-09-16

Full Automatic (NIBP) Blood Pressure Monitor

Applicant Health & Life Co., Ltd.

K-Number K190507

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LLZ 2019-09-16

SubtleMR

Applicant Subtle Medical, Inc.

K-Number K191688

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HRS 2019-09-16

AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws

Applicant Industrias Medicas Sampedro S.A.S

K-Number K191641

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NGT 2019-09-15

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe

Applicant Medline Industries, Inc.

K-Number K191378

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LPL 2019-09-13

Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens

Applicant Visco Vision, Inc.

K-Number K183670

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EBF 2019-09-13

Infinix Universal Composite

Applicant Nobio , Ltd.

K-Number K182921

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