10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00531351·
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704506358·
CarePoint Precision
FDA UDI
ALLISON MEDICAL, INC.·00786227053851·3ml Luer Lock Syringe w/ 23g x 1.5”
IMAGE3 SE DISPOSABLE FULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)
FDA 510(k)
FDA Class 2
·Immunology
ALTRUA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 11, 2013
CONSULTA CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·April 13, 2011
ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE -12 MM DIAMETER, 100 MM
FDA Adverse Event
Injury
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GCJ·May 19, 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