14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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