20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DMRC Dual Cure Orthodontic Band Cement
FDA 510(k)
FDA Class 2
·Dental
PMD-2000 INTERFERENTIAL STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
FDA 510(k)
FDA Class 2
·Neurology
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·June 3, 2013
SYMBIQ SCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 30, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 21, 2011
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·November 27, 2019
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·April 13, 2017
BIT, DRILL
FDA Adverse Event
Malfunction
·SYNTHES, USA·Product code HTW·October 14, 2016
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·June 9, 2021
XIA TITANIUM 4.5 BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·September 3, 2020
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·December 10, 2020
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·April 5, 2022
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·March 7, 2017
HANDLE FOR 90° SCREWDRIVER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·January 29, 2019
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·April 7, 2017
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·March 6, 2020
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·December 24, 2019
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015