12 results
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31ms
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Sources: EU EUDAMED, US FDA
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Country: United States
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Generic Buccal Tubes
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746153839·DB TUBE INCONEL UL 2ND MOL 022 T-10 R6D 4.5MM
HARDYDISK CEFOPERAZONE, 75 MCG
FDA 510(k)
FDA Class 2
·Microbiology
SUMMIT DUOFIX HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PS CONSTRAINED INSERT XLG
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·July 20, 2017
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·April 2, 2013
CLINAC
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS·Product code IYE·March 18, 2011
LAB BOVIE PENCIL
FDA Adverse Event
Malfunction
·COVIDIEN VALLEY·Product code GEI·April 17, 2008
SUMMIT DUOFIX TAP SZ5 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 12, 2015
BD PHOENIX¿ PMIC-108
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 25, 2024
BD PHOENIX¿ PMIC-108
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 19, 2024
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