10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
Ceramco®
FDA UDI
Dentsply International Inc.·D00119715140·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049736·Steinmann Pins, Single trocar, round end, .0938...
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
FDA 510(k)
FDA Class 2
·Cardiovascular
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
FDA 510(k)
FDA Class 2
·Cardiovascular
QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·July 10, 2017
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2013
GORE-TEX® SOFT TISSUE PATCH
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FTL·July 31, 2014
IAB : 8 FR - 40 CC FOS
FDA Adverse Event
Injury
·ARROW INTL., INC.·Product code DSP·January 21, 2011
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