BEUDAMED
    18 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ, SKU 900723 SUPER POLIGRIP ADH CREAM .75OZ, SKU 900085

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·November 15, 2023

    Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 6, 2017

    Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 6, 2017

    Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 6, 2017

    Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 6, 2017

    Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc disease, B. Spondylolisthesis, C. Trauma, D. Spinal Stenosis, E. Deformities, F. Tumor, G. Pseudoarthrosis, and H. Revision of previous surgery. The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy and nitinol components. The system is attached to the anterior aspect of the vertebral body by means of screw to to the cervical spine.

    FDA Enforcement
    Class II ·Terminated·Orthofix, Inc·March 5, 2014

    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical·January 29, 2025

    Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view

    FDA Enforcement
    Class II ·Ongoing·Haag-Streit USA Inc·December 30, 2020

    HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.

    FDA Enforcement
    Class II ·Terminated·Haag-Streit USA Inc·September 11, 2019

    HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.

    FDA Enforcement
    Class II ·Terminated·Haag-Streit USA Inc·September 11, 2019

    HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.

    FDA Enforcement
    Class II ·Terminated·Haag-Streit USA Inc·September 11, 2019

    FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56

    FDA Enforcement
    Class II ·Ongoing·G & H Wire Company·February 14, 2024

    Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone.

    FDA Enforcement
    Class II ·Terminated·G & H Wire Company·March 10, 2021

    Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.

    FDA Enforcement
    Class II ·Terminated·W & H DentalWerk Burmoos GMBH - Site 1·April 18, 2018

    Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Inc Mortara·April 28, 2021

    Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B ACL- LF DYNJ905281B ACL PACK DYNJ67271A ALIF DYNJ904848L ANTERIOR CERVICAL DYNJ901355J ARTHROSCOPY DYNJ908193B ARTHROSCOPY PACK-LF DYNJ42963M DYNJ52268B ARTHROSCOPY SHOULDER DYNJ908684A BACK CDS-LF CDS983364G BACK PACK DYNJT4339 CDH SPINE PACK DYNJ908828D CERVICAL CDS DYNJ903477J CMC ORTHO BACK TRAY SYNJ10272B CRANIOTOMY DYNJ911853 CRANIOTOMY ROOSEVELT PACK DYNJ58358F CUSTOM HAND PACK-LF DYNJ0537135V CUSTOM SPINAL PACK DYNJT7544 DISCECTOMY PACK DYNJ86770 DJ ORTHO SPINE DYNJ48980M EXTREMITY PACK-LF DYNJT4161 FOOT PACK DYNJ53179D GENERAL ORTHO-ACNW DYNJ84891 GILMORE SHOULDER SCOPE PACK DYNJ58002 GV LUMBAR LAMINECTOMY PK DYNJ46938L HAND PACK DYNJ63113B DYNJ69662A DYNJT5855 HAND-LF DYNJ903263B KIT LAMINECTOMY DYNJ908806C KNEE ARTHROSCOPY DYNJ902056C DYNJ904846I KNEE ARTHROSCOPY-LF DYNJ905871F KNEE SCOPE DYNJ906986G LAMINECTOMY DYNJ904847K DYNJ909505D LAMINECTOMY CDS CDS983115K LAMINECTOMY CERVICAL DISC-LF DYNJ905286G LAMINECTOMY NEURO PACK DYNJ58356F LAMINECTOMY SPINE DYNJ904139L LOWER EXTREMITY PACK DYNJ63114C LUMBAR CERVICAL PACK-LF DYNJ0101088G LUMBAR LAMI DYNJ905020J LUMBAR LAMINECTOMY DYNJ53707 LUMBAR LAMINECTOMY PACK DYNJT4386 MAIN/LAMINECTOMY PACK-LF DYNJ0565499AN NJ SPINE SPECIALIST PACK DYNJ58706F OHOW SPINE-BACK PACK DYNJ910097A ORTHO NECK CDS-LF CDS983134C ORTHO PACK-LF DYNJ37202G ORTHO SPINE DYNJ40221G OSC BEACH CHAIR SHOULDER-LF DYNJ905282C PACC PETRIE ACL ADD ON PACK-LF DYNJ58290D PACK,ARTHROSCOPY ASC DYNJ65484A PACK,POSTERIOR SPINAL FUSION DYNJ906892B PAD LATERAL SPINE DYNJ902158L DYNJ902158M PAD POSTERIOR SPINE DYNJ902142L PK-SPINE DYNJ58259A PODIATRY PACK DYNJ62288D POST SPINE PACK DYNJ20509R POSTERIOR SPINAL FUSION DYNJ903250B RFT ARTHROSCOPY PACK DYNJ43956C RFT SHOULDER PACK-NOBLE DYNJ36331D SA SHOULDER #2 BORDEN DYNJ56501A SHOULDER DYNJ900893M DYNJ904184I SHOULDER ARTHROSCOPY DYNJ904842G SHOULDER PACK DYNJ83483 SHOULDER PACK-LF DYNJ42973N SHOULDER SCOPE PACK NTX DYNJ68399C SPINAL PACK DYNJ49692G SPINE DYNJ910451A SPINE PACK DYNJ20147O DYNJ84971 DYNJ86044A DYNJ86308C DYNJ88917 DYNJS3069 DYNJT4163 DYNJT8396 ST CHARLES TOTAL HIP DYNJ909593C TOTAL HIP DYNJ910906D TOTAL HIP PACK DYNJ64156B TOTAL JOINT DYNJ904186G TOTAL KNEE PACK DYNJ60967 DYNJ61409A WMC ORTHO SPINE WMC-LF DYNJ902528M XLIF DYNJ910795B

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical·January 29, 2025