11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set
FDA 510(k)
FDA Class 2
·General Hospital
ReVeneer Adhesive Set
FDA UDI
Schütz Dental GmbH·ESDG2322051·ReVeneer is an intraoral and extraoral repair s...
STRAIGHTSHOT
FDA UDI
DEPUY MITEK, LLC·10886705011025·STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 8.5mm
BodiTrak
FDA UDI
Vista Medical Ltd·07540150602820·Hi-Res Seat
RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·November 14, 2008
NONE
FDA Adverse Event
Injury
·Product code KGX·August 26, 2011
DAILY ACTIVITY ASSIST DEVICE
FDA Adverse Event
Malfunction
·FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.·Product code IKX·October 4, 2012
INVIVE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code NKE·January 24, 2019
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