18 results
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19ms
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Sources: EU EUDAMED, US FDA
ZOLL PAD
FDA 510(k)
FDA Class 3
·Cardiovascular
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033273234·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033273265·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033273289·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033273210·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033273227·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033273272·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033273258·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033273296·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033273302·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033273241·
DATA MASTER PERFUSION MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SONDREX P.A.L. SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 19, 2013
UNK DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 4, 2011
DELTA VALVE REG, LEVEL 1.5
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·March 11, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
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