25 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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Noxilizer Surgical Ruler
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LEONE SPA
FDA UDI
LEONE SPA·08033707017523·CALIBRA 1ST MOLAR BANDS n.LR 1
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016827·1.6mm/2.0mm Screw Visidisk Logic
OsteoMed
FDA UDI
OSTEOMED LLC·00842528126714·3.0/4.0mm Cannulated Cntrsnk, Quick Release
MULTIFUNCTIONAL LINEAR PEN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMPLANTIUM II
FDA 510(k)
FDA Class 2
·Dental
ASSURITY RF DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVZ·January 9, 2024
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 21, 2021
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 1, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 17, 2014
ENDURITY MRI
FDA Adverse Event
Injury
·ABBOTT·Product code LWP·October 3, 2022
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 4, 2018
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 28, 2016
Artis Q floor, Model Number 10848280
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
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
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 Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis 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.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020