15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Porcine Mineral Collagen Composite
FDA 510(k)
FDA Class 2
·Dental
Crown - D2
FDA UDI
Sprintray, Inc.·00850039704864·SprintRay Crown is a light-curable polymerizabl...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112724·BARRON VACUUM PUNCH 6.75MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112687·BARRON CORNEAL PUNCH 9.25MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112823·BARRON VACUUM PUNCH 9.25MM
BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 17, 2022
CS 9600
FDA 510(k)
FDA Class 2
·Radiology
Vortex Radial Spray Catheter
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·October 16, 2008
OPTISENSE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 28, 2013
PROFEMUR MODULAR NECK
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code KWA·April 22, 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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025