17 results · 22ms · Sources: EU EUDAMED, US FDA

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LASSO NAV DUO LOOP CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450200186·

ALEUTIAN Interbody Systems

FDA UDI
VB Spine LLC·10888857560710·Disc Spreader Size 6 mm

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

M-SERIES

FDA UDI
Savaria Concord Lift·10688503001778·Patient Lifter

EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM

FDA 510(k)
FDA Class 1 ·General Hospital

NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·December 11, 2014

AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 23, 2013

AMISTEM H FEMORAL STEM SIZE 5 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·December 9, 2014

RETAIN-SLEEVE LONG F/MATRIX 5.5

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code LXH·May 24, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Injury ·DEXCOM, INC.·Product code MDS·September 30, 2014

ATTAIN OTW

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

13 CM TRICUT BLADE

FDA Adverse Event
Malfunction ·MEDTRONIC ENT (JACKSONVILLE)·Product code HAW·July 23, 2015

CURVED SINUS BURS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EQJ·June 2, 2014

Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.

FDA Enforcement
Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

FDA Enforcement
Class II ·Terminated·Senseonics, Inc.·November 6, 2019