18 results
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21ms
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Sources: EU EUDAMED, US FDA
Planmeca ProMax 3D Max, Planmeca Maximity
FDA 510(k)
FDA Class 2
·Radiology
LEONE SPA
FDA UDI
LEONE SPA·08033707017578·CALIBRA 1ST MOLAR BANDS n.LR 6
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857248243·Osteotome, Size 30 mm
STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022
SPRINT
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2013
GRIPPER MICRO NEEDLE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code FPA·July 1, 2011
ADVIA CENTAUR CP
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·September 11, 2008
ROOT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·September 20, 2018
VIDAS® LYME IGM ASSAY
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LSR·September 25, 2015
Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 3, 2013
Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 28, 2016
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 26, 2015
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015