9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IUR RECIPROCATING MORCELLATOR MODEL # 7210517
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
R120 MODULAR TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·November 25, 2025
5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·April 8, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 6, 2011
VITALITY AVT FAST-CHARGE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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