15 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ECHELON OVAL V6.0A MRI System
FDA 510(k)
FDA Class 2
·Radiology
FlexBoard™ base
FDA UDI
MACROMEDICS B.V.·08720168160492·FlexBoard base module + bottomstop
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780360964·Integra® Miltex® Microsurgery Scissors 7", Curv...
Lacrimal Dilator
FDA UDI
KATENA PRODUCTS, INC.·00841668108635·WILDER LACRIMAL DILATOR #1
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100820·FLIERINGA FIXATION RING 21MM
STERILE LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN
FDA 510(k)
FDA Class 1
·Physical Medicine
U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·BERRY PLASTICS QINGDAO LTD.·Product code HEB·October 31, 2022
U BY KOTEX : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·BERRY PLASTICS QINGDAO LTD.·Product code HEB·January 5, 2022
U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·BERRY PLASTICS QINGDAO LTD.·Product code HEB·June 28, 2023
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 11, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 22, 2011
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·September 23, 2008
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc·October 3, 2018
Allura Xper FD20/15; System Code: 722058;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026