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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.

    FDA Enforcement
    Class II ·Terminated·Illumina Inc·September 17, 2014

    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

    Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·January 1, 2014

    Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1 OXY-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Oxycodone (OXY)", X11-IS1 BZO-DX / "Alere iScreen" Dx Single Dip Card Single Drug Detection: Benzodiazepine (BZO300)", X11-IS1 MET-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Methamphetamine (MET)", X11-IS1 AMP-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Amphetamine (AMP)", X11-IS1 MDM-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Ecstasy (MDMA)", X11-IS1 MTD-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Methadone (MTD)", X11-IS1 MOP-DX/"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Morphine (MOP)", X11-IS1 THC-DX/"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Marijuana (THC)", X11-IS1 TCA-DX/ "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Tricyclic Antidrepessants (TCA)", X11-IS1 PCP-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Phencyclidine (PCP)",

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use

    FDA Enforcement
    Class II ·Terminated·Life Technologies, Corp.·October 24, 2018

    MIM software; System, Image Processing, Radiological

    FDA Enforcement
    Class II ·Ongoing·MIM Software Inc·March 12, 2025

    Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J; 6) PLASTICS PACK, Kit SKU DYNJ68288A; 7) IMPLANT REMOVAL KIT, Kit SKU MNS13035; 8) PLASTICS PACK-LF, Kit SKU PHS41746D.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 4, 2026

    Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST AUGMENTATION PACK DYNJ68023 FACIAL PLASTIC DYNJ909926C JVL - MODULE PLASTIC PK DYNJ84081B KIT MAJOR PLASTICS MOSES DYNJ905362C MEM MAXILLOFACIAL PACK-LF DYNJ0660040R MINOR BREAST PACK DYNJ89023A PLASTIC MAJOR SURGERY DYNJ902510M PLASTIC PACK DYNJ84766 PLASTIC PACK-LF DYNJ0578842M PLASTICS EXTREMITY PACK DYNJ63803C PLASTICS PK - NO SYR DYNJ62433D RR-ASC-RHINOPLASTY PACK-LF DYNJ81772C TRANSGENDER PACK DYNJT7588 WH PLASTIC MAJOR PACK DYNJ89048A

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

    Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) TYMPANOPLASTY PACK, REF DYNJ50692C; 5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B; 6) FREE FLAP CUSTOM PACK A, REF DYNJ82735; 7) NSR-SMR, REF DYNJ903144C; 8) KIT FACIAL MINORPLASTICS MOSES, REF DYNJ905365A; 9) SEPTOPLASTY, REF DYNJ906474; 10) SEPTOPLASTY, REF DYNJ906474A; 11) FREE FLAP, REF DYNJ907802; 12) MINOR DIEP, REF DYNJ907863; 13) MAIN FLAP, REF DYNJ908264.

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 8, 2025