15 results
·
22ms
·
Sources: EU EUDAMED, US FDA
LifeSPARC System
FDA 510(k)
FDA Class 2
·Cardiovascular
CVS Health
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428639290·Flexible Fabric Antibacterial Bandages, assorte...
NA
FDA UDI
Synthes GmbH·10886982151636·2.4MM CANNULATED SCREW LONG THREAD 30MM
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981247133·No-Profile Interbody, 35mm x 27mm x 18mm, 30 Deg
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2118300·2.4mm Cannulated Screw, Long Thread, 30mm
Diamond Orthopedic, LLC
FDA UDI
DIAMOND ORTHOPEDIC, LLC·B551DMD2118300·2.4mm, Cannulated Screw, Long Thd., 30mm
TRI-FIX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO
FDA 510(k)
FDA Class 2
·Cardiovascular
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code MTA·October 29, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011
M2A-MAGNUM PF CUP 50ODX44ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 8, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025