23 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ADVANCE UNICONDYLAR KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RADIESSE DERMAL FILLER
FDA Adverse Event
Injury
·BIOFORM MEDICAL, INC.·Product code LMH·December 8, 2009
ADVIA® Chemistry ISE Buffer - 2 liter
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414209968·ISE Buffer - ADVIA Chem. - CONS - 2 Liter
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033568781·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033568804·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033568811·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033568774·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033568736·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033568767·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033568743·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033568750·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033568798·
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
FDA 510(k)
FDA Class 2
·Orthopedic
TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ECAREMANAGER V3.6
FDA Adverse Event
Malfunction
·VISICU·Product code MSX·September 21, 2009
ECAREMANAGER V3.6
FDA Adverse Event
Malfunction
·VISICU·Product code MSX·December 14, 2009
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
REGENCY SC+
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
ICY HOT HEAT THERAPY PATCH
FDA Adverse Event
Other
·CHATTEM, INC.·Product code IMD·March 13, 2008
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
FDA Enforcement
Class II
·Ongoing·Intuitive Surgical, Inc.·June 10, 2026