15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TriMed Ripcord Device
FDA 510(k)
FDA Class 2
·Orthopedic
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025040·G73 Dry Bath Incubator
Gregory Profunda Clamp (Small-Baby) 15.5cm
FDA UDI
Geister Medizintechnik GmbH·04057034057025·Gregory Profunda Clamp (Small-Baby)
15.5cm
Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·00190660194673·Corneal trephine blade, short, 8.0mm length, 6....
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68169102206500·6.5mm Cannulated Screw Kit
POISE PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ITRAK 35001
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 31, 2008
DEFIBRILLATOR/PACEMAKER
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 25, 2013
POLARIS ADJUSTABLE VALVE WITH ANTECHAMBER
FDA Adverse Event
Malfunction
·SOPHYSA·Product code JXG·June 30, 2011
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 5, 2018
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 19, 2018
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code PUB·November 15, 2024
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