BEUDAMED
    26 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

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

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

    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No

    FDA Enforcement
    Class II ·Ongoing·Edan Diagnostics·January 28, 2026

    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No

    FDA Enforcement
    Class II ·Ongoing·Edan Diagnostics·January 28, 2026

    MIM software; System, Image Processing, Radiological

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

    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

    TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·October 9, 2019

    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

    Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No

    FDA Enforcement
    Class II ·Ongoing·Edan Diagnostics·January 28, 2026

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 16, 2018

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 16, 2018

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 16, 2018

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 16, 2018

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 16, 2018

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 16, 2018

    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

    TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    RIGHT HEART CATH LAB KIT FOR BAPTIST MEM. HOSP., Item No. 46071-40 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016