17 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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