16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
FDA 510(k)
FDA Class 2
·Orthopedic
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 8, 2013
SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code MEG·November 12, 2019
CD HORIZON
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 11, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·December 29, 2010
VENTAK PRIZM
FDA Adverse Event
Malfunction
·GUIDANT CLONMEL IRELAND·Product code LWS·April 9, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·March 28, 2011
BIPOLAR POROUS
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·March 5, 2024
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 6, 2020
TERUMO PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·February 6, 2023
PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·January 6, 2024
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·April 15, 2025
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