20 results · 23ms · Sources: EU EUDAMED, 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