8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MITEK ABSORBABLE ANCHOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X400MM X 12
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012
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
AMS 700 LGX MS PUMP 12
FDA Adverse Event
Malfunction
·AMS·Product code FHW·December 16, 2010
BIOPATCH 4150
FDA Adverse Event
Injury
·INTEGRA NEUROSCIENCES PR·Product code FRO·January 29, 2013
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·July 17, 2014
PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 45CM P/N 0250080729 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