8 results
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34ms
·
Sources: EU EUDAMED, US FDA
LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Multi-Unit DAS System
FDA 510(k)
FDA Class 2
·Dental
FUJIFILM Endoscope Models EC-600HL and EC-600LS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AXIOM ARISTOS VX PLUS
FDA Adverse Event
Injury
·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2014
ON-Q PAINBUSTER
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·December 16, 2010
REM 2000 35X80 DARTEX NO FB
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code IKY·February 5, 2013
PKG, BLAKESLY BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080293. 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