11 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033652·Baltic Denture System BDLoad BDLoad Ln6 PLSEbi...
YASARGIL PERM MINI-CLIP SLT-CVD 4.7MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code HCH·February 19, 2014
REMECURE MODEL CL 15E
FDA 510(k)
FDA Class 2
·Dental
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SCORPIO NRG PS FEMORAL #5 RIGHT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 3, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·February 11, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 25, 2014
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 14, 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