11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
IMMUCHEM COVALENT-COAT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR28221401·Betaflex wires Titanium Straight-Arch-F. mand. ...
Stradis Healthcare
FDA UDI
STRADIS MEDICAL, LLC·M7526822140·General Surgical Kit
Invenio
FDA UDI
Gri-Alleset, Inc.·00840365905370·Sanger Heart Procedure Pack
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M7526822140R10·
WHISPER WEAR BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LEKSELL STEREOTACTIC SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 20, 2014
PULSAR GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 5, 2015
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024