13 results
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19ms
·
Sources: EU EUDAMED, US FDA
XLTEK NEUROPATH, MODEL PK1070
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024312203·
NA
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024312210·
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LASER 3 SPSC300
FDA 510(k)
FDA Class 2
·Physical Medicine
CER BIOLOXD OPTION HD 36MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·October 28, 2024
CER OPTION TYPE 1 TPR SLEVE +6
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·October 28, 2024
EMERGE¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·April 11, 2013
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code LHI·September 2, 2014
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011
AV FISTULA , Model No UTAV77T
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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