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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Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
FDA 510(k)
FDA Class 2
·Anesthesiology
XLIF
FDA UDI
Nuvasive, Inc.·00887517191601·XLIF Blade, 100mm Lung Retractor Narrow
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704624673·RUSCH Color Coded Guedel Airway Length 100mm Tr...
REAMER HEAD 10.0mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000641·
TARGETING MODULE, TROCHANTERIC NAIL 135°/20cm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665005899·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113769·AIR INJECT CANNULA 30GA
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702820164·ELVAREX 3/KNEE HIGH/SLANT-CLOSED TOE/DOTTED 5 C...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR19812231001·Slim line expander 8 mm
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 20, 2024
ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
FDA 510(k)
FDA Class 2
·Radiology
INTESS LUMBAR CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 4, 2014
INTRALASE FS2 LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC.·Product code HNO·August 15, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2013
Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package
FDA Recall
Terminated
·Lang Dental Mfg Co, Inc.·Product code EBI·June 7, 2004
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 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