13 results
·
18ms
·
Sources: EU EUDAMED, US FDA
COVER, LIMB
FDA 510(k)
FDA Class 1
·Physical Medicine
ACUMED
FDA UDI
Acumed LLC·10806378050459·Polarus® 3 Proximal Targeting Guide, R
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209130498·
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580162700001·SURE-SNAP 1. MOLAR UPR RGT SZ 27
IPLAN
FDA 510(k)
FDA Class 2
·Neurology
TRIFIX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
DANYANG HUAYI MEDICAL SUPPLY&EQUIPMENT CO.,LTD·Product code INM·May 9, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007
LOGIC FEMORAL PS CEM RIGHT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 1, 2024
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