13 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CODMAN HAKIM MICRO II VALVE
FDA 510(k)
FDA Class 2
·Neurology
LEONE SPA
FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450218433·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450462461·
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 31, 2023
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
FDA 510(k)
FDA Class 2
·Cardiovascular
READYSWIM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
IDENTITY ADX XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 14, 2014
ANESTAR ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code BSZ·April 30, 2013
X-SMART
FDA Adverse Event
Malfunction
·DENTSPLY MAILLEFER·Product code LQY·May 5, 2011
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