8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ELASTOPLAST
FDA 510(k)
FDA Class 1
·General Hospital
ACUMED SMALL BONE LOCKING ROD SYSTEM II
FDA 510(k)
FDA Class 2
·Orthopedic
Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
PSX INTERBODY SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER 45MM STAPLE LINE 2.5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GDW·December 17, 2007
LCP PROX TIBPL 3.5 LAT LE SHAFT 4HO L81 T
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HRS·October 11, 2012
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024