10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
FDA 510(k)
FDA Class 2
·Cardiovascular
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057370656·STRETCHER PAD 28" W X 3.5" H X 76" L STANDARD
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TC-PLUS POROUS FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·April 26, 2013
SENSOR,MMT-7002C,10PK,GLUCOSE,BSA,17L
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·April 26, 2011
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·July 24, 2008
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·March 22, 2017
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