68 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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Ingenuity Core Computed Tomography X-ray system, Model 728321
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Brilliance ICT SP Computed Tomography X-ray system, Model 728311
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
IQon Spectral CT Computed Tomography X-ray system, Model 728332
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
FDA Enforcement
Class III
·Terminated·Randox Laboratories·March 21, 2018
Ingenuity CT Computed Tomography X-ray system, Model 728326
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Penner Pacific Bathing Spa, Model Numbers 860010-1L
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
FDA Enforcement
Class III
·Terminated·SPINEART SA·December 4, 2019
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
FDA Enforcement
Class III
·Terminated·Randox Laboratories·March 21, 2018
GreenLight HPSEA Laser Fibers, UPN 0010-2092
FDA Enforcement
Class III
·Ongoing·Boston Scientific Corporation·July 27, 2022
Penner Pacific Bathing Spa, Model Numbers 360020-1P
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
FDA Enforcement
Class III
·Terminated·Sigma·July 25, 2012
BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·July 10, 2013
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
FDA Enforcement
Class III
·Terminated·Pega Medical Inc.·May 27, 2020
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
FDA Enforcement
Class III
·Terminated·Medtest Holdings, Inc.·July 5, 2017
ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc·November 26, 2014