12 results
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32ms
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Sources: EU EUDAMED, US FDA
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MARGRON STEM (K032641)
FDA Adverse Event
Injury
·PORTLAND ORTHOPAEDICS PTY LTD·Product code KWY·May 31, 2005
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·April 2, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·February 24, 2011
ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·April 22, 2008
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code MAF·July 9, 2020
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MAF·July 9, 2020
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·July 18, 2023
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.
FDA Enforcement
Class II
·Ongoing·Canary Medical, Inc.·July 16, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012