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

LZA 2019-12-17

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

Applicant Riverstone Resources Sdn Bhd

K-Number K190725

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LPH 2019-12-17

Precision Casting Solutions Total Hip System

Applicant Precision Casting Solution, LLC

K-Number K192450

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QEY 2019-12-17

Bashir Plus Endovascular Catheter

Applicant Thrombolex, Inc.

K-Number K193071

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DQO 2019-12-17

ILUMIEN System with AptiVue Software version D.3

Applicant ABBOTT MEDICAL

K-Number K192267

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DXG 2019-12-17

EV1000 Clinical Platform

Applicant Edwards Lifesciences, LLC

K-Number K193179

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OLT 2019-12-17

CNS Envision

Applicant Moberg Research, Inc.

K-Number K192572

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IPF 2019-12-17

InMode System with Tone Applicator

Applicant InMode , Ltd.

K-Number K192249

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MMX 2019-12-17

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit

Applicant Argon Medical Devices, Inc.

K-Number K191758

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NKB 2019-12-17

G Surgical Marksman System

Applicant G Surgical, LLC

K-Number K193219

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KNS 2019-12-17

Single Use Balloon Dilator V (with knife)

Applicant Olympus Medical Systems Corp.

K-Number K193039

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JAK 2019-12-17

syngo.CT CaScoring

Applicant Siemens Medical Solutions USA, Inc.

K-Number K192763

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FTM 2019-12-17

Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)

Applicant Synovis Life Technologies, Inc. (Baxter International Inc.)

K-Number K192615

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