17 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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MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PORTABLE INTENSIVE CARE UNIT, MODEL PIC
FDA 510(k)
FDA Class 2
·Anesthesiology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·October 30, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 14, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 22, 2013
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·April 27, 2011
DA VINCI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL, INC.·Product code NAY·July 3, 2008
COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·November 14, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 27, 2020
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·October 8, 2014
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022