11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
KERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083018474·STR, 10 electrode, MPD-SL, 2-8-2-8-2-8-2-8-2mm ...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111247194·KRISTELLER SPECULUM 80X30MM
ARTHREX TIBIAL GRAFTBOLT
FDA 510(k)
FDA Class 2
·Orthopedic
PHOSPHORUS REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADULT BREATHING CIRCUIT DUAL HEATED
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 30, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Injury
·CYBERONICS·Product code LYJ·January 9, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA·Product code NIQ·November 20, 2010
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
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