20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONLINE DAT PROPOXYPHENE PLUS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IM-5B MICROINJECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER
FDA 510(k)
FDA Class 1
·General Hospital
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·September 19, 2024
BD POSIFLUSH XS/SF
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·December 8, 2024
CP840442 DE LEIPZIG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·May 12, 2010
LIBERTY CYCLER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·August 23, 2011
CP025369 DE LEIPZIG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·August 3, 2011
CP85315 IT MODENA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·January 14, 2013
CP84050 FR LA REUNION
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·May 17, 2012
CP84042 DE LEIPZIG %
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWE·April 20, 2011
D905 DIDECO EOS SINGLE HVR
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·September 25, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·April 9, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 15, 2011
ENDOTAK C
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
FDA Recall
Terminated
·Radiometer America Inc·Product code LKD·September 27, 2011
D905 EOS OXYGENATOR (PHISIO TREATED)
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·July 13, 2018
D905 EOS PHISIO OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·August 8, 2017
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-NT-U
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·November 25, 2002
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