22 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COULTER A T 5DIFF CAP PIERCE (CP)
FDA 510(k)
FDA Class 2
·Hematology
K042172
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·September 2, 2022
CDS 3-PD HEMATOLOGY CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 7, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 5, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 31, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 29, 2012
PELVILACE TO BIOURETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·April 4, 2013
NI
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HTY·March 28, 2011
LD CV EZTRK 2 BP IS1 4542 80CM US
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 15, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 14, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 12, 2015
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 31, 2012
VNGD SSK 360 FEMUR R 67.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 10, 2020
BMT SPLINED KNEE STM V2 12X80
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 10, 2020
BMT 360 TIB 5.0 OFFSET ADAPTER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 10, 2020
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
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