9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HCG RIA PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LEONE SPA
FDA UDI
LEONE SPA·08033707065746·INTRAORAL ELASTICS 6,5 oz 1/4" red
INTEROSSEOUS NEEDLE
FDA 510(k)
FDA Class 1
·Dental
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
FDA 510(k)
FDA Class 2
·Cardiovascular
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·May 5, 2014
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·October 15, 2012
ENDOPOUCH RETRIEVER SPEC BAG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·August 2, 2010
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 12, 2013
TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 19, 2013