9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ENDOTRACHEAL TUBE HOLDER
FDA 510(k)
FDA Class 1
·Anesthesiology
MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
SUMMIT DUOFIX TAP SZ3 STD OFF
FDA Adverse Event
Malfunction
·DEPUY WARSAW·Product code LPH·October 24, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 18, 2007
ALTRX +4 10D 36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·May 9, 2014
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 6, 2025
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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