17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Luggie Chair
FDA 510(k)
FDA Class 2
·Physical Medicine
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821601390·SCISSORS, SURGICAL TISSUE, DENTAL
SMOOTH K-WIRE, DOUBLE END BAYONET POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016257·
SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
FDA 510(k)
FDA Class 2
·Immunology
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·July 16, 2002
ONE TOUCH BASIC ENHANCED
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 24, 2002
INSERTION HANDLE FOR SUPRAPATELLAR
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code JDS·December 15, 2016
INSERTION HANDLE FOR SUPRAPATELLAR
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·January 22, 2021
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 10, 2013
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·September 19, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
20 ML DISCARDIT¿ II SYRINGE WITHOUT NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 1, 2018
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
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