15 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Varian Head Frame
FDA 510(k)
FDA Class 2
·Radiology
World Knee Tibial Monotrial - UC
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215081171·
GM HELIX IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019
VENUS FREEZE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OLYMPUS XCHF TYPE B180Y1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LPH·September 28, 2018
GM HELIX IMPLANT 6.0X8 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 21, 2019
GM HELIX IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 20, 2019
GM HELIX ACQUA IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 20, 2013
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 27, 2011
2.0MM TI MLP CURVED STRUT PLATE-MINI 8 HOLES/MALLEABLE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JEY·October 17, 2014
GM HELIX IMPLANT 6.0X8
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019
POLYETHYLENE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQO·April 5, 2022
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012