7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BODY BOOT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NOMAD MD 75K V HANDHELD X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
FDA 510(k)
FDA Class 2
·Anesthesiology
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 22, 2014
TI PROXIMAL TIBIA LISS PLATE 9 HOLES/220MM-LEFT
FDA Adverse Event
Malfunction
·SYNTHES·Product code HRS·February 4, 2013
UNKNOWN BIGLIANI/FLATOW SHOULDER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSD·December 22, 2010
PKG, DEBANEY FORCEPS, P/N 0250080314. 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