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

DZE 2016-02-05

MOR Implant System

Applicant Sterngold Dental, LLC

K-Number K153173

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BSP 2016-02-05

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle

Applicant Spectra Medical Devices, Inc.

K-Number K151069

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NUC 2016-02-05

Love Liquid Personal Lubricant

Applicant The Kama Sutra Company

K-Number K152168

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GEH 2016-02-05

Cryocare CS Surgical System

Applicant Healthtronics

K-Number K153489

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MJN 2016-02-05

Bridge Occlusion Balloon

Applicant Spectranetics, Inc.

K-Number K153530

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DXT 2016-02-04

DyeVert Contrast Modulation System

Applicant Osprey Medical, Inc.

K-Number K153141

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OUR 2016-02-04

The Entasis Dual-Lead Sacroiliac Implant

Applicant Corelink, LLC

K-Number K152237

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LJS 2016-02-04

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS

Applicant Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K-Number K153487

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OCT 2016-02-04

Medline Anti-Fog Solution

Applicant Medline Industries, Inc.

K-Number K152948

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OAP 2016-02-04

DermaScalp Laser Cap

Applicant Dermascalp, LLC

K-Number K152587

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LQY 2016-02-04

Dr's Finder

Applicant Good Doctors Co., Ltd.

K-Number K151274

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GEX 2016-02-04

NaturaLase CO2 Laser System

Applicant Focus Medical, LLC

K-Number K152529

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