7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
FDA 510(k)
FDA Class 2
·Ophthalmic
Makani Science Respiration Monitoring System
FDA 510(k)
FDA Class 2
·Anesthesiology
BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·November 11, 2014
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 25, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·July 23, 2013
PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014