BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Status: Terminated × Clear all

    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

    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

    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

    VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·November 27, 2013

    VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - 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 Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - 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