14 results · 27ms · Sources: EU EUDAMED, US FDA

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POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).

FDA 510(k)
FDA Class 1 ·General Hospital

LEONE SPA

FDA UDI
LEONE SPA·08033707065661·INTRAORAL ELASTICS 2,5 oz 5/16" blue

Tiche PTA Balloon Dilatation Catheter

FDA UDI
BrosMed Medical Co.,Ltd.·06958481476910·

FLEXIBLE ENDOSCOPIC SCISSORS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

VISION R/F TILTING TABLE

FDA 510(k)
FDA Class 2 ·Radiology

AXXENT FLEXISHIELD MINI (K090417)

FDA Adverse Event
Injury ·XOFT, INC.·Product code IXI·January 7, 2011

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 12, 2026

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NDN·March 14, 2018

CONTOUR USB

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 15, 2014

PRECISION®

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 16, 2011

An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names.

FDA Enforcement
Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

FDA Enforcement
Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

FDA Enforcement
Class II ·Ongoing·Bard Peripheral Vascular Inc·October 13, 2021