10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEOMED HEADLESS CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEMCON BANDAGE
FDA 510(k)
FDA Unclassified
·Unknown
TERUMO TCM II COOLING AND HEATING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·April 11, 2013
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·April 19, 2011
TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC·Product code NIQ·June 19, 2008
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326713
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·March 22, 2023
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015