11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PS MEDICAL CATHETER PLACEMENT KIT
FDA 510(k)
FDA Class 2
·Neurology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994248381·CASE 2940096 RETRACTOR TRAY
VARIAX
FDA UDI
Stryker GmbH·07613327129496·Wrist Fusion Drawer Labeling Clip
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122963·K-WIRE - SINGLE TROCAR 0.9mm DIA x 150mm
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
FDA 510(k)
FDA Class 2
·Cardiovascular
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 1, 2013
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 22, 2010
REPLY
FDA Adverse Event
Injury
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code NVZ·July 17, 2014
PKG, 5MM, 45CM, INSERT, DORSEY GRASPER FORCEPS, P/N 0250080736 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020