20 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FibroScan 230
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V
QUICKANCHOR ORTHOCORD
FDA UDI
Medos International Sàrl·10886705001835·Mini QUICKANCHOR Plus (Number 2/0 Suture) Size ...
PermaCem Smartmix Dual
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2120350·Permanent luting cement automix system. The hig...
Thino Roth Bracket, .022 Mini, LL5, w/o hook
FDA UDI
Astar Orthodontics Inc.·06941673501699·
MINI QA+ #2/O OCORD V-5
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code JDR·January 7, 2019
BRAUN PRECISION SENSOR PRO, MODEL BP 2590
FDA 510(k)
FDA Class 2
·Cardiovascular
VALET MICRO CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 29, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 8, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·July 8, 2013
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022
MINI QA+ #2/O OCORD V-5
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code JDR·October 15, 2021
MINI QA+ #2/O OCORD V-5
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code JDR·September 13, 2018
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (00690103172126) Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·November 27, 2019
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025