10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
FDA 510(k)
FDA Class 2
·Physical Medicine
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033544·Baltic Denture System BDLoad BDLoad Mm7 PLSEbi...
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
FDA 510(k)
FDA Class 2
·Hematology
GENZYME CONTRAST II HCG URINE/SERUM TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INSERTER-LARGE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·April 3, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 30, 2011
ALARIS SYSTEM PUMP MODULE
FDA Adverse Event
Other
·CARDINAL HEALTH ALARIS PRODUCTS·Product code FRN·April 23, 2008
EVOLUT PRO PLUS VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·October 23, 2025
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