13 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450452530·
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
FDA 510(k)
FDA Class 2
·Microbiology
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
FDA 510(k)
FDA Class 2
·Neurology
KYPHX® HV-R? BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NDN·March 14, 2014
KYPHX® HV-R? BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NDN·June 20, 2014
5.5MM TI MIN INVASIVE CURVED ROD 200MM RADIUS/125MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NKB·March 12, 2013
NO CODE AVAILABLE
FDA Adverse Event
Injury
·SYNTHES USA·Product code GXN·March 8, 2016
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 6, 2013
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·September 16, 2014
SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
FDA Adverse Event
Other
·HOLOGIC, INC.·Product code NEU·April 22, 2011
PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
FDA Adverse Event
Injury
·SYNTHES USA·Product code GWO·June 21, 2016
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