14 results · 20ms · Sources: EU EUDAMED, US FDA

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VAXCEL PLUS CHRONIC DIALYSIS CATHETER

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

Illusion Glove PF Latex Grape

FDA UDI
HENRY SCHEIN, INC.·H65810327121·Illusion Glove PF Latex Grape Medium

Illusion Glove PF Latex Grape

FDA UDI
HENRY SCHEIN, INC.·10304040101336·Illusion Glove PF Latex Grape Medium

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032712·Baltic Denture System BDLoad Ln6 PLSEbil2DFl BL...

Plateau-LO Spacer System

FDA UDI
Life Spine, Inc.·00190837027629·PLATEAU-LO Interbody, 10mm x 32mm x 12mm, 7°

ILLUSION GLOVE PF LATEX GRAPE

FDA Adverse Event
Injury ·PURNABIA ADVENTA HEALTH·Product code LYY·June 16, 2011

THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F

FDA 510(k)
FDA Class 2 ·General Hospital

NORAV HOLTER SYSTEM, MODEL NH-300 V1.07

FDA 510(k)
FDA Class 2 ·Cardiovascular

DUROM ACETABULAR COMPONENT 52/46 CODE L

FDA Adverse Event
Other ·ZIMMER GMBH·Product code KWA·March 19, 2013

VICRYL (POLYGLACTIN 910) MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code GAM·March 17, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014

Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024