12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LONG LOVE CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033541·Baltic Denture System BDLoad BDLoad ↓ Sw7 PLSEu...
SHOULDER COIL
FDA 510(k)
FDA Class 2
·Radiology
DENLASER, MODEL 800
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
MERSILENE POLYESTER FIBER SUTURE
FDA Adverse Event
Injury
·ETHICON, INC·Product code GAS·April 3, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014
ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 30, 2011
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·July 27, 2022
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024