22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58216042108·FORCEPS, RONGEUR, SURGICAL
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197059909·Piccolo Applicator, slender triangular
Ø 0,8m...
SONARA; SONARA/TEK
FDA 510(k)
FDA Class 2
·Radiology
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
Widex
FDA UDI
Widex A/S·05706069814361·Widex UNIQUE U-CIC TR (Clay brown ) 220, Left, ...
Widex
FDA UDI
Widex A/S·05706069814378·Widex UNIQUE U-CIC TR (Dark brown ) 220, Left, ...
Widex
FDA UDI
Widex A/S·05706069814354·Widex UNIQUE U-CIC TR (Light beige ) 220, Left,...
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO·Product code NVN·June 10, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code JOR·June 20, 2011
HUDSON CO2 SAMPLING CANNULA A, 7FT 2IN
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CCK·April 26, 2016
V.A.C. GRANUFOAM DRESSING
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020
HUDSON CO2 SAMPLING CANNULA A, 7FT 7FT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CCK·April 22, 2016
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
FDA Adverse Event
Injury
·ORTHOPEDIATRICS CANADA ULC·Product code HXX·October 10, 2025
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
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: 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·January 21, 2015
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