17 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MOVES SLC
FDA 510(k)
FDA Class 2
·Anesthesiology
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1614200·16mm H x 14mm W x 20mm L x 0 degrees XLIF
restor3d MTP
FDA UDI
Restor3d, Inc.·00840097505237·CoCr MTP Implant, Medium
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306820502·Babcock Forceps, 20cm
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X161420120·16mm H x 14mm W x 20mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L161420120·16mm H x 14mm W x 20mm L XLIF Trial 12 degree L...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X16142080·16mm H x 14mm W x 20mm L x 8 degrees XLIF
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311614200·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321614200·
PETITE BASIC SYSTEM 701 ELT
FDA 510(k)
FDA Class 2
·Cardiovascular
GC FUJI TEMP
FDA 510(k)
FDA Class 2
·Dental
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code LWP·June 4, 2013
REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL MITRAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·April 8, 2016
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL MITRAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·April 8, 2016
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017