14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Blade
FDA UDI
KATENA PRODUCTS, INC.·00841668113196·BARD-PARKER BLADE #11 PACK OF 50
Magicore System
FDA 510(k)
FDA Class 2
·Dental
Disposable Blade
FDA UDI
KATENA PRODUCTS, INC.·00841668113202·BARD-PARKER BLADE #15 PACK OF 50
BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·March 22, 2018
IVENT 201 PORTABLE VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
FDA 510(k)
FDA Class 2
·Immunology
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 7, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 27, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 2, 2013
LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 6, 2025
LOGIC FEMORAL PS CEM RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 4, 2024
OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 25, 2022
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