15 results · 22ms · Sources: EU EUDAMED, 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