20 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0602250·Tray, Base, 2.25"
NUVASIVE SPHERX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Sportex
FDA UDI
Diversified Products, Inc.·00842894119839·
Mini Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70602251·Mini-Mono-Brackets 4th Dim. Ricketts 'S'.018" 1...
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0604250·Tray, Base, 4.25"
DRACO
FDA UDI
HNM TOTAL RECON LLC·00841742121956·DRACO MetaFuse U Midfoot/Lisfranc Plate, Ti - (...
SETROX S 45
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code LWS·October 27, 2006
LUMOS DR-R
FDA Adverse Event
Injury
·BIOTRONIK, GMBH AND CO.·Product code LWS·October 27, 2006
DOSIMETRY CHECK
FDA 510(k)
FDA Class 2
·Radiology
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
FDA 510(k)
FDA Class 2
·Cardiovascular
PROLIFT +M PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·April 16, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 15, 2011
STERRAD 100S STERILIZER
FDA Adverse Event
Injury
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 12, 2008
CONFIDA BRECKER CURVE GUIDEWIRE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DQX·June 5, 2025
UNKNOWN BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 10, 2017
ADVIA CENTAUR XP HBC TOTAL (HBCT)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LOM·June 18, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022