42 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Picasso/Picasso Lite lasers Intended use: Dentistry.
FDA Recall
Terminated
·AMD Lasers, LLC·Product code GEX·April 15, 2010
PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 Indicated for use in photocoagulation of both anterior and posterior segments of the eye.
FDA Recall
Terminated
·Alcon Laboratories, Inc.·Product code HQF·September 26, 2008
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
FDA Recall
Terminated
·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code CIJ·July 10, 2020
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
FDA Recall
Terminated
·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JFJ·July 10, 2020
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
FDA Enforcement
Class II
·Terminated·RANDOX LABORATORIES, LTD.·September 9, 2020
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
FDA Enforcement
Class II
·Terminated·RANDOX LABORATORIES, LTD.·September 9, 2020
Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
FDA Recall
Terminated
·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·May 12, 2020
Magnesium on RX Imola analyser IVD
FDA Enforcement
Class II
·Terminated·Randox Laboratories, Limited·December 14, 2016
Magnesium on RX Imola analyser IVD
FDA Recall
Terminated
·Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom·Product code JGJ·April 14, 2016
Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
FDA Recall
Terminated
·Alcon LenSx, Inc. 33 Journey Aliso·Product code OOE·March 14, 2014
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·June 24, 2020
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·June 24, 2020
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
FDA Recall
Terminated
·Volk Optical Inc·Product code HJI·February 27, 2015
Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·June 24, 2020
WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
FDA Enforcement
Class II
·Terminated·Wright Medical Technology, Inc.·February 12, 2020
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
FDA Enforcement
Class II
·Terminated·Wright Medical Technology, Inc.·February 12, 2020
Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JWH·March 17, 2005
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
FDA Enforcement
Class III
·Terminated·Volk Optical Inc·July 15, 2015