40 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MYOSCIENCE CRYO-TOUCH
FDA 510(k)
FDA Class 2
·Neurology
Bur PM2-95 80K steel Ø1.8mm sterile
FDA UDI
Bien-Air Surgery SA·J00711004470011·
Bur PM2-95 80K Steel Ø1.8 St
FDA UDI
Bien-Air Surgery SA·17630055504026·
Digital Analogue 5.0
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059074765·
Osstell SmartPeg Type 36
FDA UDI
Osstell AB·09010522001479·ISQ Measurement Peg
EDENTA
FDA UDI
EDENTA ETABLISSEMENT·E312K90044710001·Dowel Pin 17 mm
Indus®
FDA UDI
SPINEFRONTIER, INC.·00190361001164·Invue Max, Two Level ACP, 47mm
MODIFICATION TO ACTICOAT FOAM DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BD VIPER¿ LT SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code OOI·August 14, 2023
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·May 8, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·September 19, 2014
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·May 17, 2011
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·September 25, 2024
Syngo.plaza, Picture Archiving and Communication System
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 5, 2016
Syngo.plaza VB10A, Picture Archiving and Communication System
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 5, 2016
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·May 13, 2020
Syngo.plaza, picture archiving and communications system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 8, 2017
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 6, 2016
Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012