11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033930·Baltic Denture System BDLoad BDLoad Sw7 PLSEbm...
ACE Surgical Pga 3-0 18" Ds18
FDA UDI
Surgical Specialties México, S. de R.L. de C.V.·00848782023004·003-3930 Pga 3-0 18" Ds18
FLEXTIME MAGNUM 360
FDA 510(k)
FDA Class 2
·Dental
NEUROSENSOR
FDA 510(k)
FDA Class 2
·Neurology
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code ITI·April 3, 2013
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 23, 2011
UNK DEPUY PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·April 24, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018