11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
FDA 510(k)
FDA Class 2
·Physical Medicine
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 19, 2021
ADVANCE MEDICAL DESIGNS FLUID POUCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
FDA 510(k)
FDA Class 2
·Dental
CANNULATED PARTIALLY THREADED RECONSTRUCTIVE SCREW
FDA Adverse Event
Injury
·BIOMET·Product code HSB·March 13, 2012
VITEK 2 AST-P606 ANTIMICBROBIAL SUSCEPTIBILITY TEST KIT
FDA Adverse Event
Malfunction
·BIOMÉRIEUX, INC.·Product code LON·February 23, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
J-VAC RESERVOIR
FDA Adverse Event
Malfunction
·ETHICON·Product code KOG·April 28, 2011
*
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
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
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018