7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER
FDA 510(k)
FDA Class 2
·Orthopedic
SKI VECTOR NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
ADVANCED AUTOMATIC KV
FDA 510(k)
FDA Class 2
·Radiology
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·February 5, 2013
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-VS·Product code NTE·January 3, 2011
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 18, 2014
PKG, GRASPER FORCEPS, SERRATED, P/N 0250080286. 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