19 results
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37ms
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Sources: EU EUDAMED, US FDA
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
DRILL 1.5X105MM 22MM STP J-NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·June 16, 2021
DRILL 1.5X105MM 22MM STP J-NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·April 28, 2021
DRILL 1.5X105MM 22MM STP J-NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·June 4, 2021
EURO 45, ORDER-NO.: 2064
FDA 510(k)
FDA Class 2
·Dental
MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM
FDA 510(k)
FDA Class 2
·Radiology
EEA 28MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·June 1, 2015
EEA31
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·August 31, 2015
PREMIUM PLUS CEEA* 28 INSTR. W/TILT-TOP*
FDA Adverse Event
Injury
·COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN·Product code GDW·November 4, 2015
ALIGN R URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code OTN·April 12, 2013
QUICKIE
FDA Adverse Event
Other
·SUNRISE MEDICAL, INC.·Product code IOR·June 17, 2008
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 19, 2011
DST SERIES ORVIL AUTOMATIC 25MM DEVICE
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·April 25, 2016
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·October 15, 2025
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·December 19, 2025
EEA 31MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GAG·December 11, 2015
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·August 16, 2022
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015