12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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