7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
GORE-TEX SAM FACIAL IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MOBILAIRE LIQUID OXYGEN SYSTEMS
FDA 510(k)
FDA Class 2
·Anesthesiology
COMFIT PINK POWDERED EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
STERIS SYSTEM 1E
FDA Adverse Event
STERIS CORPORATION - HOPKINS·Product code MED·February 6, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVY·January 4, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 21, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024