15 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
YANKAUER SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896091627·YANKAUER SUCTION TUBE STAINLESS STEEL
UNIBLATE ELECTROSURGICAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOL SYS 8/15.0 L LRG STAT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
ON Q PAIN BUSTER-POST OP PAIN RELIEF SYSTEM
FDA Adverse Event
Injury
·I-FLOW CORPORATION·Product code MEB·September 29, 2008
V.A.C. GRANUFOAM DRESSING
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020
TRANSVENE SVC
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·April 22, 2019
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·April 22, 2019
CAPSUREEPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·April 22, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017