13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SUPER-FLOW TUBING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CLYDESDALE PTC™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169191334·CAGE 4922245 CDALE PTC 22MM 12 DEG 12X45
Clydesdale™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994972866·CAGE 2922245 CLYDESDALE 22 12DEG 12X45
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970478·
G-FERT, MODEL 10033
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACR Screw System
FDA 510(k)
FDA Class 2
·Dental
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·February 17, 2016
CLYDESDALE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code MAX·February 19, 2025
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
METRX
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·January 18, 2013
ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·July 9, 2014
UNK
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·March 17, 2016
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015