13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE MULTILIFT
FDA 510(k)
FDA Class 2
·Physical Medicine
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040015957·Hartman Mosquito Forceps Cvd
ACCU-CHEK ® GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·August 1, 2024
CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
FDA 510(k)
FDA Class 2
·Orthopedic
CADD EXTENSION SET
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·June 11, 2025
DEVICE 8252410 NIM-NEURO 2.0 INTERFACE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code IKN·February 21, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 27, 2013
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 18, 2011
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC·Product code MIH·February 7, 2008
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
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