12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COULTER LIN-X LINEARITY CONTROL
FDA 510(k)
FDA Class 2
·Hematology
Harvard Temp C&B Pro A1
FDA UDI
Harvard Dental International GmbH·EHAR70816411·Temporary crown and bridge material 4:1
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MGB·November 26, 2025
XTD THROMBECTOMY CATHETER, XX CM
FDA 510(k)
FDA Class 2
·Cardiovascular
TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIQ·March 12, 2020
XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIQ·February 12, 2021
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Death
·PHILIPS HEALTHCARE·Product code MKJ·April 26, 2011
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 22, 2008
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
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