18 results
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70ms
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Sources: EU EUDAMED, US FDA
NORDICICE SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
PANAVIA F
FDA 510(k)
FDA Class 2
·Dental
FENNING HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 23, 2023
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 29, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 10, 2011
LINOX SD 65/18
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code LWS·July 21, 2008
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·March 28, 2023
AVAN TAP CORT SCR SS 4.5X26MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X48MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X56MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X20MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X52MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
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