15 results
·
26ms
·
Sources: EU EUDAMED, US FDA
THERMOLATOR HEATING UNIT
FDA 510(k)
FDA Class 1
·Physical Medicine
X-Box
FDA UDI
INNO Holdings, Inc.·M71188016250·PEEK, Ta
ACUMED
FDA UDI
Acumed LLC·10806378050435·Polarus® 3 Nail Targeting Locking Bolt
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209130221·
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580162500001·SURE-SNAP 1. MOLAR UPR RGT SZ 25
FLOWPICC STYLET
FDA 510(k)
FDA Class 2
·Cardiovascular
PRONOVA NONABSORBABLE SUTURE, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POLARUS® 3 NAIL TARGETING LOCKING BOLT
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·August 22, 2022
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·August 22, 2022
RESOLUTE INTEGRITY OTW
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·May 9, 2014
GYNECARE GYNEMESH* PS
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 25, 2007
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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025