9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 17, 2013
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·June 18, 2008
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·April 14, 2011
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018