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    25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.

    FDA Enforcement
    Class II ·Terminated·IDS (Immunodiagnostic Systems Ltd.)·January 23, 2013

    LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·July 5, 2017

    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen

    FDA Enforcement
    Class II ·Terminated·Immuno-Mycologics, Inc·June 17, 2020

    LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code JWH·May 30, 2017

    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen

    FDA Recall
    Terminated ·Immuno-Mycologics, Inc·Product code GMJ·November 4, 2019

    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    Microcuff Pediatric Endotracheal Tubes - Oral Pre-Curved: ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product Reference: I-MPEOC-35; ID Size: 4,0mm, Product Reference: I-MPEOC-40; ID Size: 4.5mm, Product Reference: I-MPEOC-45; ID Size: 5,0mm, Product Reference: I-MPEOC-50; ID Size: 5,5mm, Product Reference: I-MPEOC-55; ID Size: 6,0mm, Product Reference: I-MPEOC-60; ID Size: 6,5mm, Product Reference: I-MPEOC-65 and ID Size: 7,0mm, Product Reference: I-MPEOC-70 * Sterile * Single use only * Manufactured by Euromedical Industries, Sdn. Bhd., Bakar Arang Industrial Estate, 08000 Sungai Patani, Kedah, Malaysia * Distributed by: Microcuff GmbH, Hohnerweg 2-4, D-69469 Weinheim, Germany.

    FDA Recall
    Terminated ·Microcuff Gmbh Honer·Product code BTR·June 19, 2006

    Microcuff Endotracheal Tube; Pediatric Oral/Nasal Magill: ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product Reference: I-MPEDC-35; ID Size: 4,0mm, Product Reference: I-MPEDC-40; ID Size: 4.5mm, Product Reference: I-MPEDC-45; ID Size: 5,0mm, Product Reference: I-MPEDC-50; ID Size: 5,5mm, Product Reference: I-MPEDC-55; ID Size: 6,0mm, Product Reference: I-MPEDC-60; ID Size: 6,5mm, Product Reference: I-MPEDC-65 and ID Size: 7,0mm, Product Reference: I-MPEDC-70 * Sterile * Single use only * Manufactured by Euromedical Industries, Sdn. Bhd., Bakar Arang Industrial Estate, 08000 Sungai Patani, Kedah, Malaysia * Distributed by: Microcuff GmbH, Hohnerweg 2-4, D-69469 Weinheim, Germany.

    FDA Recall
    Terminated ·Microcuff Gmbh Honer·Product code BTR·June 19, 2006

    Microcuff Adult Endotracheal Tubes - Oral/Nasal Magill with Murphy Eye * ID Size: 5,0mm, Microcuff Product Reference: I-HMICU-50; ID Size: 5.5mm, Product Reference: I-HMICU- 55; ID Size: 6.0mm, Product Reference: I-HMICU- 60; ID Size: 6.5mm, Product Reference: I-HMICU- 65; ID Size: 7.0mm, Product Reference: I-HMICU- 70; ID Size: 7.5mm, Product Reference: I-HMICU-75; ID Size: 8.0mm, Product Reference: I-HMICU-80; ID Size: 8.5mm, Product Reference: I-HMICU-85; ID Size: 9.0mm, Product Reference: I-HMICU-90; and ID Size: 10.0mm Product Reference: I-HMICU-10 * Sterile * Single use only * Manufactured by Euromedical Industries, Sdn. Bhd., Bakar Arang Industrial Estate, 08000 Sungai Patani, Kedah, Malaysia * Distributed by: Microcuff GmbH, Hohnerweg 2-4, D-69469 Weinheim, Germany.

    FDA Recall
    Terminated ·Microcuff Gmbh Honer·Product code BTR·June 19, 2006

    LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·July 5, 2017

    IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code CIN·August 10, 2012

    LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code JWH·May 30, 2017

    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code NEO·August 10, 2012

    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code JIT·August 10, 2012

    Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.

    FDA Enforcement
    Class III ·Terminated·Covidien LLC·May 22, 2013

    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.

    FDA Enforcement
    Class II ·Terminated·Intersurgical Inc·January 15, 2020

    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.

    FDA Enforcement
    Class II ·Terminated·Intersurgical Inc·January 15, 2020

    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent, Inc.·August 17, 2016