22 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
FDA 510(k)
FDA Class 1
·General Hospital
Forearm Plate, Curved
FDA UDI
I.T.S. GmbH·09120047307212·Forearm Plate, Curved, 11-Hole
IMAGEN Parainfluenza Virus Types 1, 2 and 3
FDA UDI
OXOID LIMITED·05032384502974·
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383535700·Gutta Percha Points is used to root canal filin...
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024183·B-P MODULAR EXTENSION W/ULTRACOAT - 11 MM X 100 MM
VARIOUS DENTAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT
FDA Adverse Event
Injury
·COVIDIEN·Product code NIO·March 7, 2017
PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code NIO·March 7, 2017
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014
SECURA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2011
V.A.C. GRANUFOAM DRESSING
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·May 3, 2016
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
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
LMA MADgic, Atomization Device with 3mL Syringe, 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 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