10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
FDA 510(k)
FDA Class 2
·Hematology
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TEH LIN JUPITER POWER CHAIR, MODEL TL-320
FDA 510(k)
FDA Class 2
·Physical Medicine
QUIK-COMBO PACING/DEFIBRILLATION/ECG
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998
IMP,1-PC,ANG,3.0X13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 19, 2024
IMP,1-PC,ANG,3.0X13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 11, 2019
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 11, 2013
BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·September 2, 2014
S-ROM M HEAD 36MM +9
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 7, 2011
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