16 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVA EMPTY SOLUTION CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
Pratt Ex large, Light Weight
FDA UDI
MEDGYN PRODUCTS, INC.·M803030888·Pratt Ex large, Light Weight 73-75 Fr (24.3-25 mm)
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 24, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 24, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 30, 2021
SANSIBAR CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SIDEPORT PINCH CLAMP DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 13, 2017
NEWPORT
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 16, 2017
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·Product code KWP·November 2, 2021
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·Product code KWP·November 2, 2021
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·Product code KWP·November 2, 2021
ATS 750 TOURNIQUET SYSTEM (ENGLISH)
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code KCY·March 28, 2013
SERIES 20000 LEGACY
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 4, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
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