11 results
·
17ms
·
Sources: EU EUDAMED, US FDA
LASER-DIL
FDA 510(k)
FDA Class 1
·Hematology
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994896346·LID 1850095 GENERIC METAL IMPLANT LID
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117469·Distal Reamer (Hudson)
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111566·Modular Stem 9mm x 150mm
ReDs Wearable System
FDA 510(k)
FDA Class 2
·Cardiovascular
All-Suture Dual Anchor System
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·November 26, 2012
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code HDD·September 28, 2010
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143
FDA Enforcement
Class I
·Ongoing·Medtronic Xomed, Inc.·July 31, 2024