50 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GC Temp Print
FDA 510(k)
FDA Class 2
·Dental
ECHO BI-METRIC MICROPLASTY HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304697959·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198109·AK3 PS Insert Trial Size 1, 13mm
Power Dental USA
FDA UDI
Power Dental U.S.A. Inc.·D943193113·TREPHINE BUR LONG SINK 5mm / 4.2mm X 21.0mm, TO...
VASCULAIRE COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
VSP SYSTEM
FDA Adverse Event
Injury
·3D SYSTEMS·Product code DZJ·December 18, 2020
THERAPY ABLATION CATHETER
FDA Adverse Event
Malfunction
·IRVINE BIOMEDICAL, INC.·Product code LPB·October 6, 2008
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON ¿ IRVINE TECHNOLOGY CENTER·Product code HQC·June 25, 2013
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2011
Quanta System Sterile Optical Laser Fiber, single use
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·May 11, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·July 17, 2023
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·July 17, 2023
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·May 28, 2024
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·June 21, 2024
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·January 15, 2025
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·January 14, 2022