8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
QUANTIFY(901)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PARA-PAK CLEAN VIAL
FDA 510(k)
FDA Class 1
·Pathology
NEXFIX COMPRESSION PIN
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 21, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·January 21, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 1, 2014
XP-XP Tibial Tray - Interlok 67 mm Item # 195753
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024