10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FORTE GAMMA CAMERA SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033254·Baltic Denture System BDLoad BDLoad Sw7 PLSEbm...
CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001
FDA 510(k)
FDA Class 2
·General Hospital
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION
FDA Adverse Event
Injury
·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·April 3, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·March 30, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·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