29 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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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
Magnesium on RX Imola analyser IVD
FDA Enforcement
Class II
·Terminated·Randox Laboratories, Limited·December 14, 2016
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/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
STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
FDA Enforcement
Class II
·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·December 21, 2022
Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
FDA Enforcement
Class II
·Ongoing·Haag-Streit USA Inc·May 19, 2021
Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·June 24, 2020
Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
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
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
Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Enforcement
Class III
·Terminated·Volk Optical Inc·June 3, 2015
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·December 16, 2015
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·December 16, 2015
Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and most other forms of organic material Ready to use. Non-toxic, latex-free and neutral pH. Safe to use on all surgical instruments, flexible endoscopes and probes.
FDA Enforcement
Class II
·Terminated·Madison Polymeric Engineering·March 6, 2019
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Enforcement
Class III
·Terminated·Volk Optical Inc·March 27, 2013
Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
FDA Enforcement
Class II
·Terminated·Alcon LenSx, Inc.·April 16, 2014
Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·March 5, 2014