9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLYMEDCO OC AUTO MICRO 80 FOB TEST
FDA 510(k)
FDA Class 2
·Hematology
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0144080·Trial, TLIF, 32L OB STR 7Deg, 8mm
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981177010·Steep DTS Guide, 8mm
KSEA VASCULAR FIBERSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESORBABLE CRANIAL CLAMPS
FDA 510(k)
FDA Class 2
·Neurology
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 8, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011
CONTAK RENEWAL 4
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 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