16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813148·GENUMEDI PRO SILVER SIZE I
JOBST UltraSheer
FDA UDI
BSN MEDICAL, INC.·00035664007263·ULTRA SHEER 20-30 MM HG KNEE HIGH EXTRA LARGE W...
Vatech Clismile
FDA UDI
Rayence Co., Ltd.·08800018601235·This product is an orthodontic bracket and is u...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450666456·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970386·
SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
FDA 510(k)
FDA Class 2
·Hematology
REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·February 5, 2010
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·February 14, 2024
SYSTEM 6 PRECISION HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code KIJ·May 20, 2013
RESTORESENSOR MRI
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 26, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 1, 2011
XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 18, 2017
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 2016
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012