20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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priti multidisc ZrO2 High Translucent
FDA 510(k)
FDA Class 2
·Dental
LoFric® Sense™
FDA UDI
Wellspect AB·07333387021737·Single Use Urinary Catheter with salt solution....
LoFric® Sense™
FDA UDI
Wellspect AB·07392532086083·Single Use Urinary Catheter with salt solution....
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304549937·
Young
FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·00302731610252·Young DPA Vera, Contra Elite Original, Latex Fr...
ILLY NEEDLE
FDA UDI
H.S. HOSPITAL SERVICE SPA·08033055143349·AGO TIPO ILLINOIS 16GX10-25MM
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467507812·16-Channel Customized Single-Use Antroduodenal ...
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·March 19, 2024
ACCUTECH ENDOLITE PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRIGEN LOW PROFILE BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
KIT IMPLANTABLE SLIM TIP LEAD, 90CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·November 19, 2025
KIT IMPLANTABLE SLIM TIP LEAD, 90CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·November 19, 2025
TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·November 9, 2006
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
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 17, 2011
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017
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
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012