8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CHOLEDOCHOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100585·LIEBERMAN TEMPORAL SPECULUM K-WIRE
MULTISPIRO-BREEZE
FDA 510(k)
FDA Class 2
·Anesthesiology
SIMMONS PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER M/L TAPER HIP MODULAR FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·December 1, 2010
SKYLINE VARIABLE S-D SCW, 14MM
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code MNI·January 15, 2013
ETS FLEX ARTICNG LNR CUTR 45MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 7, 2014
PKG, BIPOLAR FORCEPS, FENESTRATED, 45CM, P/N 0250080350. 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