17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FlexWing Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Sensi-Disc™ Minocycline 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902312513·BD BBL™ Sensi-Disc™ Minocycline 30 µg
SPROTTE® 2.G
FDA UDI
Pajunk GmbH Medizintechnologie·14048223024239·SPROTTE® 2.G
Standa...
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021437·INTRG WHISP MBT CUS HK 0T +3A 018 LR
SPROTTE®
FDA UDI
Pajunk GmbH Medizintechnologie·04048223108222·Distal Tip: SPROTTE®
Proximal End: ISO 80369-7
Rx Knee Femoral Cone Augment Reamer Size Medium
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215147822·
CarboClear Navigated Instruments
FDA 510(k)
FDA Class 2
·Neurology
TRINITY ELE
FDA 510(k)
FDA Class 2
·Neurology
RELION INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 30, 2020
UNKNOWN DELTA VALVE
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·July 15, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 1, 2011
CUB PEDIATRIC CRIB- HYD BASE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FMS·July 17, 2013
BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025