13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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4CIS SARA Spine System, 4CIS VERTU Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
NAVIGATION COMPUTER, TGS V2 W/ SOFTWARE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·May 22, 2017
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113547·SLIT BLADE 3.2MM ANGLED (BX/5)
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113561·IMPLANT BLADE 6.2MM (BX/5)
GLOBAL UNITE Platform Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
SCENARIA View
FDA 510(k)
FDA Class 2
·Radiology
TEM PUMP 2232
FDA Adverse Event
Malfunction
·RICHARD WOLF MEDICAL INSTRUMENTS·Product code FJL·October 8, 2008
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 5, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013
VENA SEAL CLOSURE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code PJQ·March 3, 2026
CLOSUREFAST CATHETER
FDA Adverse Event
Injury
·COVIDIEN·Product code GEI·March 3, 2026
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