10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SCALPEL HANDLE #3 SS 410 OR 420
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177744·11mm, 4-Hole Threaded Anterior Plate
Kwik Kleen
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657072151·Kwik Kleen Kerrison 2mm x 180mm x 90 Deg
Parcus GFS Naked
FDA 510(k)
FDA Class 2
·Orthopedic
EMJOI TENS DEVICE
FDA 510(k)
FDA Class 2
·Neurology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 4, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 30, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021