22 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO CLEARFIL SE BOND
FDA 510(k)
FDA Class 2
·Dental
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00124421·
NC TREK
FDA UDI
ABBOTT VASCULAR INC.·08717648151514·NC TREK Coronary Dilatation Catheter 4.50 mm x ...
NC TREK
FDA UDI
ABBOTT VASCULAR INC.·08717648151491·NC TREK Coronary Dilatation Catheter 4.50 mm x ...
NC TREK
FDA UDI
ABBOTT VASCULAR INC.·08717648151521·NC TREK Coronary Dilatation Catheter 4.50 mm x ...
NC TREK
FDA UDI
ABBOTT VASCULAR INC.·08717648151507·NC TREK Coronary Dilatation Catheter 4.50 mm x ...
DISNEY
FDA UDI
FGX INTERNATIONAL INC.·00193033409268·
DISNEY
FDA UDI
FGX INTERNATIONAL INC.·00193033409305·
DISNEY
FDA UDI
FGX INTERNATIONAL INC.·00193033409299·
DISNEY
FDA UDI
FGX INTERNATIONAL INC.·00193033409312·
DISNEY
FDA UDI
FGX INTERNATIONAL INC.·00193033409282·
DISNEY
FDA UDI
FGX INTERNATIONAL INC.·00193033409275·
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
FDA 510(k)
FDA Class 2
·General Hospital
PLUM A+ - ANIMAL HEA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·January 21, 2015
OVATIO
FDA Adverse Event
Injury
·SORIN CRM·Product code MRM·March 15, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 9, 2011
ARCOAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·March 13, 2008
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