12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AFFIRM CO2 AND AFFIRM CO2 HP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TASMIN R 8°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014752·The basic shape of the TASMIN R devices is a ho...
IL TEST PROS
FDA 510(k)
FDA Class 2
·Hematology
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
FDA 510(k)
FDA Class 2
·General Hospital
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·November 4, 2015
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 26, 2013
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·April 29, 2011
MDT FEDALIS ICD LEAD
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code LWS·July 25, 2008
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·November 17, 2017
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LIT·May 23, 2016
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015