9 results · 26ms · Sources: EU EUDAMED, US FDA

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REAGENT GPT, ENZYME

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

The Orthodontic Store

FDA UDI
Young Innovations, Inc.·00843471183182·.022 L/L Std. Weld Size #14

FLOWMETER, OXYGEN

FDA 510(k)
FDA Class 1 ·Anesthesiology

ACL AcuStar

FDA 510(k)
FDA Class 2 ·Hematology

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 3, 2012

PRAXIAR GRAB 'N GO III

FDA Adverse Event
Malfunction ·PRAXAIR HEALTHCARE·Product code CAN·February 18, 2014

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·July 21, 2010

Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.

FDA Enforcement
Class II ·Terminated·Battle Creek Equipment Co.·November 9, 2016

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024