17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ARGYLE A-V MEDI-WING HEMODIALYSIS SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PULSE
FDA UDI
Nuvasive, Inc.·00887517814128·PULSE Cart Power and Data Cable
ACUMED
FDA UDI
Acumed LLC·10806378050367·Polarus® 3 Long T15 Hexalobe Driver
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209127849·
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580161800001·SURE-SNAP 1. MOLAR UPR RGT SZ 18
Nalu Neurostimulation SCS system
FDA 510(k)
FDA Class 2
·Neurology
SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET
FDA 510(k)
FDA Class 2
·Cardiovascular
POLARUS® 3 PLATE DRILL GUIDE, DROP-IN
FDA Adverse Event
Malfunction
·ACUMED LLC·Product code LXH·May 23, 2018
POLARUS® 3 LONG T15 HEXALOBE DRIVER
FDA Adverse Event
Malfunction
·ACUMED LLC·Product code LXH·May 23, 2018
POLARUS® 3 2.8MM SHORT DRILL
FDA Adverse Event
Malfunction
·ACUMED LLC·Product code LXH·May 23, 2018
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code FTL·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007
POLARUS® 3 LONG T15 HEXALOBE DRIVER
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·November 27, 2024
POLARUS® 3 PROXIMAL LOCKING NAIL 150MM L
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·January 8, 2025
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022