11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
GERBER PRECIOUS CARE ELECTRIC BREAST PUMP
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
HEPARIN LOCK FLUSH SOLUTION 100 UNITS/ML
FDA Adverse Event
Death
·AMSINO MEDICAL USA·Product code NZW·June 3, 2008
CLO-SURPLUS P.A.D.
FDA 510(k)
FDA Unclassified
·Unknown
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2014
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·November 12, 2010
FORTIFY VR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 8, 2013
HEPARIN 100U/ML
FDA Adverse Event
Death
·AMSINO·Product code NZW·March 7, 2008
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·November 12, 2025
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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