9 results
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25ms
·
Sources: EU EUDAMED, US FDA
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
FDA 510(k)
FDA Class 2
·Radiology
Brigade
FDA UDI
Nuvasive, Inc.·00887517961891·Brigade Lateral Trial, 10x34x28mm 10°
FERMIT N PLUS
FDA 510(k)
FDA Class 2
·Dental
POLARIS CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 30, 2014
TRIDENT HEMISPHERICAL SOLID BK 48MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·November 12, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 14, 2012
ON-Q C-BLOC WITH DUAL SELECT-A-FLOW 600 ML X 1-7 ML/HR + 1-7 ML/HR
FDA Adverse Event
Injury
·AVANOS MEDICAL - IRVINE·Product code MEB·November 21, 2019
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