21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Z-Clamp ISP System
FDA 510(k)
FDA Class 2
·Orthopedic
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304250819·
CODMAN
FDA UDI
Cerenovus, Inc.·10886704000464·CODMAN ELSBERG Ventricular Cannula Silver 7 Fr.
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321610160·
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467505511·CUSTOMIZED SINGLE-USE ANORECTAL 16CH CATHETER
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467505603·CUSTOMIZED SINGLE-USE ANTRODUODENAL 16CH CATHETER
EDENTA
FDA UDI
EDENTA ETABLISSEMENT·E312C1613160161·Surgical cutters FGXL
Symmetry Rochester-Pean
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482040201·Symmetry® Forceps, Rochester-Pean Hemostatic, S...
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780511526·CODMAN® ELSBERG ELSBERG Ventricular Cannula Sil...
ANS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EBI ESL PEEK-OPTIMA SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Beyes
FDA UDI
Beyes Dental Canada Inc·00990010306363·HP CARBIDE BONE CUTTER 161-016
Beyes
FDA UDI
Beyes Dental Canada Inc·00990010303188·RA CARBIDE BONE CUTTER 161-016
Beyes
FDA UDI
Beyes Dental Canada Inc·00990010304819·FG CARBIDE BONE CUTTER 161-016
REDUCED SIZE SCREW EXPANDABLE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 20, 2018
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·June 17, 2011
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). Furthermore Sympathic Tone and Parasympathic Tone are calculated by power spectral analysis of ECG (heart rate variability) and continuous blood pressure (blood pressure variability) as well as the Baroreceptor Reflex Sensitivity (BRRS). For use by medically trained personnel. It has been designed for diagnoses aiding and must not be used for vital sign monitoring of critically ill patients under absence of additional, suitable self-monitoring devices or medical trained personnel. The device measures continuously the subject's hemodynamic parameters without reporting any diagnosis. It is the physician's responsibility to make proper judgment based on these parameters.
FDA Enforcement
Class II
·Terminated·Partners In Medicine Llc·January 13, 2016