11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496032748·VENERE 140, SIZE XL, GLACE, GRADUATED COMPRESSI...
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032748·Baltic Denture System BDLoad Mn6 PLSEbim6DFm BL...
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FLASH-LITE II LED DENTAL CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 3, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 29, 2011
GUARDIAN ROLLING WALKER
FDA Adverse Event
Malfunction
·A&E·Product code ITJ·April 18, 2008
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018