17 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SafeCross Transseptal Puncture and Introducer (TSP/I) System
FDA 510(k)
FDA Class 2
·Cardiovascular
KIT BD MAX EXT ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·January 27, 2021
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
FDA 510(k)
FDA Class 2
·Radiology
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC.·Product code MCM·October 17, 2008
MAXIMO II VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 7, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 5, 2026
GLENOID RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 15, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 20, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 22, 2025
GLENOID RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PHX·May 26, 2026
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 29, 2024
GLENOID RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·April 14, 2026
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·November 20, 2013
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