11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Glenoid Baseplate with Screw
FDA 510(k)
FDA Class 2
·Orthopedic
AccuQuest
FDA UDI
Bernafon AG·05711584087978·AQ CO1 B 105, 2.4G NFM DPB MAC/MSIL ACCUQ
MED-RX EXTENSION SET WITH T-CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
CLARISO PACS
FDA 510(k)
FDA Class 2
·Radiology
NDEHP PLUMSET 2CLAVES-SL
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·September 29, 2021
NV GXL LINER LIPPED 36MM ID GROUP 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·December 15, 2023
AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·May 3, 2013
LONG NAIL KIT R2.0, TI, RIGHT 11X360MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code JDS·October 8, 2008
RA CATH SET: 20 GA X 1-1 /2
FDA Adverse Event
Malfunction
·ARROW INTERNACIONAL INC·Product code DQX·July 20, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025