9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET
FDA 510(k)
FDA Class 2
·General Hospital
LARGE FRONT WHEELS WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
WIRE
FDA 510(k)
FDA Class 1
·Orthopedic
DUROM ACETAULAR COPONENT
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·May 20, 2014
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·November 12, 2012
TRIDENT PSL HA SOLID BACK 52MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·September 20, 2010
T25 STARDRIVE SHAFT F/MATRIX LONG
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·April 25, 2023
PKG, 5MM INSERT, ENDO GRASPER, 33CM, P/N 0250080699 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
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015