11 results · 23ms · Sources: EU EUDAMED, 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