14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032930·Baltic Denture System BDLoad Sm6 PLSEbm6DFs B4 ...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776178390·HANK DILATOR FR
INSTACCULT
FDA 510(k)
FDA Class 2
·Hematology
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PEN NDL 32G 4MM 100BX 1200 USA
FDA Adverse Event
Malfunction
·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·March 18, 2024
PEN NDL 32G 4MM 100BX 1200 USA
FDA Adverse Event
Malfunction
·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·February 16, 2024
PEN NDL 32G 4MM 100BX 1200 USA
FDA Adverse Event
Malfunction
·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·February 16, 2024
OASYS IN-SITU ROD BENDER RIGHT
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code LXH·April 3, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 29, 2011
INDURA
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·April 23, 2008
INTELLIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 2, 2023
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
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