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

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    Filters Classification: Class Ii ×

    Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz 3 Zweimueller Type Stem SCS-Standard Sz 4 Zweimueller Type Stem SCS-Standard Sz 5 Zweimueller Type Stem SCS-Standard Sz 6 Zweimueller Type Stem SCS-Standard Sz 7 Zweimueller Type Stem SCS-Standard Sz 8 Zweimueller Type Stem SCS-Standard Sz 9 Zweimueller Type Stem SCS-Standard Sz 10 Zweimueller Type Stem SCL-Lateralized Sz 3 Zweimueller Type Stem SCL-Lateralized Sz 4 Zweimueller Type Stem SCL-Lateralized Sz 5 Zweimueller Type Stem SCL-Lateralized Sz 6 Zweimueller Type Stem SCL-Lateralized Sz 7 Zweimueller Type Stem SCL-Lateralized Sz 8 Zweimueller Type Stem SCL-Lateralized Sz 9 Zweimueller Type Stem SCR-Revision Sz 3 Zweimueller Type Stem SCR-Revision Sz 4 Zweimueller Type Stem SCR-Revision Sz 5 Zweimueller Type Stem SCR-Revision Sz 6 Zweimueller Type Stem SCR-Revision Sz 7 Zweimueller Type Stem SCR-Revision Sz 8 Zweimueller Type Stem SCR-Revision Sz 9 Zweimueller Type Stem SCR-Revision Sz 10 Zweimueller Type Stem SCR-Revision Sz 11 Variety of hip and knee implants and instruments, multiple uses.

    FDA Enforcement
    Class II ·Terminated·Orthopedic Alliance LLC·June 5, 2013

    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.

    FDA Enforcement
    Class II ·Terminated·Euro Diagnostica AB·March 14, 2018

    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·April 11, 2018

    ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·September 20, 2023

    ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·May 4, 2022

    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·January 1, 2014

    ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·September 10, 2014

    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro/8/9/10000) Part Number: 0020302600

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·October 27, 2021

    TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN: 00763000421304 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·May 26, 2021

    Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·May 26, 2021

    OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·July 15, 2020

    OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·July 15, 2020

    ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·April 5, 2023

    ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·April 5, 2023

    ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·April 5, 2023

    ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·April 5, 2023

    ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

    FDA Enforcement
    Class II ·Terminated·Stryker Corporation·March 14, 2018

    Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·December 30, 2020

    Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·December 30, 2020