15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1
FDA 510(k)
FDA Class 2
·Cardiovascular
FALLS CREEK
FDA UDI
FGX INTERNATIONAL INC.·00193033500286·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134150·Trial, TLIF, 27L OB STR 7Deg, 15mm
FALLS CREEK
FDA UDI
FGX INTERNATIONAL INC.·00708820706194·
CARE PROVIDER STATION ADDITION OF WEIGHT SCALE
FDA 510(k)
FDA Class 2
·Cardiovascular
VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
CELSITE ACCESS PORT
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL SAS·Product code LJT·October 23, 2014
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 20, 2013
XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·February 3, 2011
SELECT SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·March 10, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 9, 2013
UNK
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·October 11, 2010
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014