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

EOB 2019-09-06

Rhino-Laryngo Videoscope Olympus ENF-VT3

Applicant Olympus Medical Systems Corp.

K-Number K183416

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HGX 2019-09-06

Willow Wearable Breast Pump 2.0

Applicant Exploramed Nc7, Inc.

K-Number K191577

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GEI 2019-09-06

Secret RF Smartcure Applicator with electrodes

Applicant Ilooda Co,., Ltd.

K-Number K182355

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PSV 2019-09-06

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F

Applicant Olympus Medical Systems Corp.

K-Number K183525

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FLL 2019-09-06

Reusable Temperature Probe

Applicant Shenzhen Caremed Medical Technology Co., Ltd.

K-Number K182751

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GZF 2019-09-06

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4

Applicant Nalu Medical, Inc.

K-Number K191435

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HAW 2019-09-06

Microscope Navigation

Applicant Brainlab AG

K-Number K190250

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PGY 2019-09-06

Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)

Applicant Barco N.V.

K-Number K191845

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LPL 2019-09-06

Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens

Applicant Lentechs, LLC

K-Number K191121

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LZA 2019-09-06

Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs

Applicant Ever Global (Vietnam) Enterprise Corporation

K-Number K190403

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FMF 2019-09-06

Sure-Fine Insulin Syringes

Applicant Shina Med Corporation

K-Number K191531

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JOJ 2019-09-05

Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label

Applicant STERIS Corporation

K-Number K192020

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