14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAVIPRO
FDA 510(k)
FDA Class 2
·Neurology
Safco DENTA-SAFE DENTAL DAM
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063750227·Heavy (0.23mm-0.28mm thickness) 6" x 6", green,...
PEDIATRIC FIXATION RODS
FDA 510(k)
FDA Class 2
·Orthopedic
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR
FDA 510(k)
FDA Class 2
·Orthopedic
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JIS·March 5, 2012
ACCESS® VITAMIN B12
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012
EXTRACTION SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·March 26, 2013
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MGB·March 16, 2011
SYNTHES
FDA Adverse Event
Injury
·SYNTHES - WEST CHESTER·Product code KWQ·March 27, 2008
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
ACCESS® VITAMIN B12
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012
EVOLUT PRO PLUS VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·July 21, 2025
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·April 22, 2019
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