9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
FDA 510(k)
FDA Unclassified
·Unknown
CHIMAERA Hip Fracture System
FDA UDI
ORTHOFIX SRL·18056099649209·M8 CONICAL MALLET ADAPTOR
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM
FDA 510(k)
FDA Class 2
·Radiology
MPS450 MULTIPARAMETER SIMULATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 2019
ISOFLEX S
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC, CRMD·Product code NVN·January 13, 2014
RONG ANGL-UPWARDS W/4 L330
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTX·June 27, 2013
TRIAGE PROFILER SOB 25 TEST KIT
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code NBC·July 28, 2011
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