16 results
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19ms
·
Sources: EU EUDAMED, US FDA
HCI GENERAL PURPOSE CATHETER STYLET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FUSE ™ SPINAL SYSTEM
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169245600·DISTRACTOR 2870014 DISTRACTOR 14MM
GC Initial™
FDA UDI
Gc America Inc.·J0228700141·GC Initial™ MC Paste Opaque OD2, 3g
GC Initial™
FDA UDI
Gc America Inc.·15400556702465·GC Initial™ MC Paste Opaque OD2, 3g
Trimline
FDA UDI
ORMCO CORPORATION·00889989051872·UPPER LEFT SECOND MOLAR TRIMLINE BAND SIZE 14
LEONE SPA
FDA UDI
LEONE SPA·08033707032939·WEB 1ST MOLAR BANDS n.LL 14
Arthrex®
FDA UDI
ARTHREX, INC.·00888867313798·Drill Guide, 1.2 / 1.6mm
DRILL GUIDE, 1.2 / 1.6MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code MDM·June 1, 2021
BACTERIA SAMPLER
FDA 510(k)AUTO DETECT FOR TELAHEART DR200/E-A
FDA 510(k)
FDA Class 2
·Cardiovascular
DRILL BIT, MINI AO, 1.2MM, CALIBRATED
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HTW·June 1, 2021
EQUINOXE CAGE GLENOID L, POST AUG, LEFT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·April 29, 2024
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 12, 2014
GMK TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 6, 2012
ISOFLEX S LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·June 25, 2015
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