13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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4CH FLEX SPEEDER
FDA 510(k)
FDA Class 2
·Radiology
ASSI
FDA UDI
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION·00841645119302·Fomon Rasp, 21cm Double Ended Str., TC Ends 7mm...
Velocity™ Expandable Interbody System
FDA UDI
Spine Wave, Inc.·10840642106879·Expandable Implant, 55(L) X 18(W) X 8-13(H) 10 ...
FINESS ENDOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NAVIGUS II TRAJECTORY GUIDE
FDA 510(k)
FDA Class 2
·Neurology
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·December 21, 2020
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 8, 2018
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 14, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 23, 2014
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORP·Product code LZG·May 25, 2011
DEKA SMARTXIDE² TRIO
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 31, 2023
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
FDA Enforcement
Class III
·Terminated·Diagnostica Stago, Inc.·September 24, 2014
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021