8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X400MM X 12
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012
STORZ UNIVERSAL EYE SHIELD
FDA 510(k)
FDA Class 1
·Ophthalmic
COBRA ADHERE SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·May 30, 2014
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 22, 2012
ZIMMER PERIARTICULAR LOCKING TIBIAL PLATE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRS·September 16, 2010
PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 29CM, P/N 0250282047 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