27 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRAFLEX EV HEMOSTASIS INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·November 15, 2017
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·November 15, 2017
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·December 2, 2011
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 27, 2019
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·April 9, 2013
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·September 30, 2014
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·March 30, 2018
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·February 11, 2010
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·July 12, 2017
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·April 12, 2016
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·October 3, 2019
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·February 17, 2017
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·July 17, 2019
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·July 17, 2019
HS III PROXIMAL SEAL SYSTEM 4.3MM
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·April 12, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 21, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·June 19, 2008