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

GDW 2019-07-16

OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners

Applicant Davol Inc., Subsidiary of C.R. Bard

K-Number K191287

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NUC 2019-07-16

Sage 2-in-1 Personal Lubricant and Moisturizer

Applicant Fairhaven Health, LLC

K-Number K190150

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LJE 2019-07-16

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set

Applicant Cook Incorporated

K-Number K183051

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NKA 2019-07-16

iBreastExam

Applicant Ue Lifesciences, Inc.

K-Number K190575

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OAS 2019-07-16

Orthophos S

Applicant Dentsply Sirona

K-Number K191616

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HSX 2019-07-16

EMPOWR Partial Knee

Applicant Encore Medical L.P.

K-Number K191325

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FDS 2019-07-16

FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L

Applicant Fujifilm Corporation

K-Number K183572

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HEB 2019-07-15

Rael Tampon

Applicant Rael, Inc.

K-Number K182814

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DQY 2019-07-15

087 Balloon Guide Catheter System

Applicant Q'Apel

K-Number K190749

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NHA 2019-07-15

A.B. DENTAL DEVICES Dental Implants System

Applicant A.B. Dental Device , Ltd.

K-Number K182455

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LPH 2019-07-15

MicroPort CoCr Femoral Heads

Applicant Microport Orthopedics, Inc.

K-Number K190123

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CFN 2019-07-15

Optilite IgM Kit

Applicant The Binding Site Group , Ltd.

K-Number K191635

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