12 results · 22ms · Sources: EU EUDAMED, US FDA

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ESTILUX UV SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

VELLA 5% Sodium Fluoride Varnish Bubble Gum Box 100

FDA UDI
Preventech·D024770113·VELLA 5% Sodium Fluoride Varnish Bubble Gum Box...

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136513·

The Orthodontic Store

FDA UDI
Young Innovations, Inc.·00843471182321·.022 U/L Std. Weld Size #13

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197447874·Love Gruenwald SWIVEL Rongeur 11.0 c...

SPONGE, LAPAROTOMY GAUZE

FDA 510(k)
FDA Unclassified ·Unknown

pixium 4343RCE

FDA 510(k)
FDA Class 2 ·Radiology

SOFTCLIX ® LANCET DEVICE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·April 24, 2014

IMPELLA RECOVER LP 2.5, .018 GUIDEWIRE

FDA Adverse Event
Malfunction ·ABIOMED EUROPE GMBH (GERMANY)·Product code KFM·October 1, 2012

LIFEPAK 15 MONITOR/DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·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 REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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