21 results
·
20ms
·
Sources: EU EUDAMED, US FDA
BIOPLATE RESORBABLE BONE SCREW
FDA 510(k)
FDA Class 2
·Dental
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304133543·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304133703·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304133628·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304133567·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304133666·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304133642·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304133581·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304133604·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304133680·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304133529·
JET THERAPY
FDA 510(k)
FDA Class 1
·Physical Medicine
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
FDA 510(k)
FDA Class 2
·Neurology
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 18, 2008
AXON DIGITAL PREAMPLIFIER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·March 1, 2013
DURASTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·March 4, 2011
ASCENSIA BREEZE2 TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·March 11, 2008
VITEK® 2 GRAM POSITIVE ID TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LQL·August 29, 2018
OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
FDA Enforcement
Class II
·Terminated·Ulrich Medical USA Inc·May 3, 2017