13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RANDOX LIPOPROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040010860·Zirlux 16+ C1 100X22
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
FDA 510(k)
FDA Class 2
·Immunology
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·August 4, 2016
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018
CD HORIZON
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 15, 2017
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007
MAVERICK²¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·March 19, 2013
ON-Q PAINBUSTER
FDA Adverse Event
Injury
·I-FLOW CORP.·Product code MEB·March 7, 2011
AMS 800 URINARY CONTROL SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EZY·October 15, 2019
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018