20 results · 24ms · Sources: EU EUDAMED, 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