8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RUBELLA IGG
FDA 510(k)
FDA Class 2
·Microbiology
KETAC CEM U
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
FDA 510(k)
FDA Class 2
·Neurology
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 9, 2014
LOW PROFILE SELF-TAPPING BONE SCREW 6.5MM X 20MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·November 18, 2010
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
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