23 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UNI KNEE SURGETICS NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20621461·Arch wires Titanol Budget mand. .018"x.025"
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY
FDA 510(k)
FDA Class 2
·Radiology
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 8, 2025
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 6, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 13, 2008
SYNCHRO GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 8, 2010
PASS LP - LIAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013
SYNCHRO GUIDEWIRE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010
SYNCHRO-14 STRAIGHT 200-35CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 12, 2023
SYNCHRO-10 STRAIGHT 200CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·October 13, 2023
SYNCHRO-14 STRAIGHT 200-35CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·November 13, 2023
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
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
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