15 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Symani Surgical System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272423681·Dental Intraligamental Anesthetic Power Syringe...
SARSTEDT, INC.
FDA registration
SARSTEDT, INC.·7 products·🇺🇸 United States
NOBLUS DIAGNOSTIC ULTRASOUND SCANNER
FDA 510(k)
FDA Class 2
·Radiology
PRACTIX CONVENIO
FDA 510(k)
FDA Class 2
·Radiology
NOBLUS ULTRASOUND SCANNER
FDA Adverse Event
Malfunction
·Product code IYO·March 30, 2017
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 16, 2015
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 16, 2015
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 19, 2014
INNER SHAFT FOR REMOVAL SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code OVE·November 11, 2014
COULTER® LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·September 10, 2011
PWRD ECH FLEX 45MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 2013
IMP,TSV,MCOL MG,4.1MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 16, 2021
IMP,TSV,MCOL MG,3.7MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 16, 2021
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014