20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Safety Blood Collection Needles with/without Needle Holder
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109331096·Nail cap for Fixion interlocking intramedullary...
Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·00190660194772·Corneal trephine blade, short, 8.0mm length, 9....
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702397505·Elvarex 2/Thigh High/Slant-Closed Toe-Elephanti...
TALOS®-C
FDA UDI
SpineArt SA·07640375236661·STERILE TALOS®-C (HA) PEEK CONVEX IBFD
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522209000·
Tib Canal Reamer Bushing
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215124960·
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
FDA 510(k)
FDA Class 2
·Hematology
DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 23, 2011
HT50 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·November 3, 2014
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·July 11, 2013
RESTYLANE DEFYNE
FDA Adverse Event
Injury
·Q-MED·Product code LMH·June 15, 2023
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015
GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).
FDA Enforcement
Class II
·Ongoing·LivaNova USA, Inc.·February 5, 2025