10 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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LPS
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033959·Baltic Denture System BDLoad BDLoad ↓ Mn7 PLSEu...
Masterline
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746164668·INSTRUMENT MASTERLINE THREE JAW STRAIGHT PLIERS
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
FDA 510(k)
FDA Class 2
·Immunology
BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DOUBLE FENESTRATED GRASPER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·April 3, 2013
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·Product code NBW·March 30, 2011
VISX LASER
FDA Adverse Event
Injury
·VISX·Product code LZS·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