9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Polyscrew Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028871·PESSARY, MARLAND #2, W/SUPPORT, 2.25"
ALL-IN-ONE
FDA 510(k)
FDA Class 2
·Dental
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
FDA 510(k)
FDA Class 2
·Dental
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 6, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 6, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·December 13, 2018
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024