10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PIONEER PLUS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
ASTRA TECH
FDA Adverse Event
Injury
·ASTRA·Product code DZE·May 5, 2011
SETROX S 45
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·July 23, 2008
ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JJE·March 19, 2004
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