9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032914·Baltic Denture System BDLoad Sm7 PLSEbm6DFs B4 ...
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
SONICWAVE SONIC PLAQUE REMOVER
FDA 510(k)
FDA Class 1
·Dental
5.0 CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 29, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 29, 2011
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 25, 2014
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