11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FORMALDEHYDE REUSE CART
FDA Adverse Event
Injury
·RENAL SCIENTIFIC SERVICES·Product code LIF·February 13, 1996
TULIP ALGINATE IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
HEALTHVIEW ECG MANAGER
FDA 510(k)
FDA Class 2
·Cardiovascular
ATLAS II PLUS DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 17, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI PLANT - ST. PAUL·Product code NVY·July 12, 2013
CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
FDA Enforcement
Class II
·Ongoing·Young Dental Manufacturing I, LLC·November 15, 2023
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025