22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029042496·Asian 4 Bicuspid Extraction
STABILIZ FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CELESTEION, PCA-9000A/2
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTRING III PROXIMAL SEAL SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code DXC·October 6, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 26, 2013
REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·December 11, 2025
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023
REVOLUTION CENTRIFUGAL BLOOD PUMP COATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·November 11, 2024
REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·December 2, 2022
REVOLUTION PHISIO CENTRIFUGAL PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·June 23, 2021
REVOLUTION PHISIO CENTRIFUGAL PUMP
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code KFM·May 20, 2021
CENTRIFUGAL PUMP REVOLUTION 5
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·August 3, 2023
CENTRIFUGAL PUMP REVOLUTION 5
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·August 3, 2023
AVAN REINF RING SS 48/58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·September 14, 2022
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023
REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·March 17, 2023
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022