11 results
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18ms
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Sources: EU EUDAMED, US FDA
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT
FDA 510(k)
FDA Class 2
·Ophthalmic
Safco T&F Bur - 30 Bladed
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310241643·Safco T&F bur - 30 bladed, fine finish carbide,...
GREAT TOE IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
E-SCAN XQ
FDA 510(k)
FDA Class 2
·Radiology
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDI·March 27, 2013
V200 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·March 18, 2011
AED PRO
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 25, 2008
OT INDUO METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 30, 2011
OT INDUO METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 10, 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
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013