9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Phoenix Sinus Tarsi Stent System
FDA 510(k)
FDA Class 2
·Orthopedic
Patient Contoured Implant-PEEK (PCI-PEEK)
FDA 510(k)
FDA Class 2
·Neurology
ELECSYS PROBNP IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 5, 2014
ZIMMER TRABECULAR METAL GLENOSPHERE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWT·September 13, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 29, 2013
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026