BEUDAMED
    17 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355; b) ENDO BASIC KIT, Pack Number DYKE1356; c) ENDOSCOPY KIT, Pack Number DYKE1771C

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack Number DYNJ908104B; b) PLASTIC MAJOR, Pack Number DYNJ908106B; c) ABDOMINOPLASTY W/LIPO SUCTION, Pack Number DYNJ909946; d) PLASTIC, Pack Number DYNJ909951

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDIOVASC ADULT, Pack Number DYNJ905472B; f) AV FISTULA, Pack Number DYNJ908096A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR, Pack Number DYNJ908099B; c) HEAD & NECK, Pack Number DYNJ908101B; d) NASAL FESS, Pack Number DYNJ908105B; e) NASAL-LF, Pack Number DYNJ908429; f) MASTOPEXY-CANNOVA, Pack Number DYNJ909948

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C; b) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0323C; c) ANESTHESIA CIRCUIT ADULT, Pack Number DYNJAA0378A; d) ADULT ANESTHESIA CIRC LAGUNA, Pack Number DYNJAA10579; e) BREATHING CIRCUIT # 34827, Pack Number DYNJAAF6674I

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pack Number CDS981515D; d) MAJOR-LF, Pack Number DYNJ900709C; e) MAJOR-LF, Pack Number DYNJ900709D; f) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723C; g) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723D; h) CYSTO, Pack Number DYNJ908098A; i) MINOR LAPAROTOMY, Pack Number DYNJ908428; j) MERCY TIFFIN BASIC LAP-LF, Pack Number DYNJ909730

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1666; c) SUCTION CANISTER KIT, Pack Number DYKM2196; d) SUCTION CANISTER KIT, Pack Number DYKM2196H; e) BRONCH LAB PACK-LF, Pack Number DYNJ24810B; f) THORACIC, Pack Number DYNJ907991F; g) RECTAL, Pack Number DYNJ908108A; h) ROBOTIC, Pack Number DYNJ908109C; i) CERVICAL, Pack Number DYNJ908748D; j) LAMI, Pack Number DYNJ908750D; k) MERCY TIFFIN BASIC-LF, Pack Number DYNJ909731; l) MERCY TIFFIN LITHOTOMY, Pack Number DYNJ909735; m) BASIC GENERAL SET UP, Pack Number DYNJ909945; n) BASIC GENERAL SET UP, Pack Number DYNJ909945A; o) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289; p) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289H; q) MTHZ TOTAL HIP, Pack Number DYNJC9311M; r) BRONCH KIT, Pack Number P906877

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L; b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D; c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F; d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C; e) LAMINECTOMY, Pack Number DYNJ908091B; f) PODIATRY, Pack Number DYNJ908092C; g) ANTERIOR TOTAL HIP, Pack Number DYNJ908095B; h) CRANI, Pack Number DYNJ908097A; i) HIP PINNING, Pack Number DYNJ908102B; j) (76) LOWER EXTREMITY, Pack Number DYNJ908103B; k) SHOULDER ARTHROSCOPY, Pack Number DYNJ908110B; m) HAND-LF, Pack Number DYNJ908425; n) TOTAL JOINT, Pack Number DYNJ908660A; o) MERCY TIFFIN HAND, Pack Number DYNJ909734; p) MERCY TIFFIN TOTAL KNEE, Pack Number DYNJ909738; q) MTHZ KNEE ARTHROSCOPY, Pack Number DYNJ909740; r) ACL-WHSC, Pack Number DYNJ910074A; s) EXTREMITY-WHSC, Pack Number DYNJ910077; t) EXTREMITY-WHSC, Pack Number DYNJ910077A; u) KNEE ARTHROSCOPY-WHSC, Pack Number DYNJ910080A; v) MICRODISC, Pack Number DYNJ910370; w) MTHZ TOTAL HIP, Pack Number DYNJC9311L

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission(NMT) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. K092027 CARESCAPE Monitor B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI. K131414 CARESCAPE MONITOR B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Thermodilution and pulse contour), Temperature, Mixed Venous Oxygen Saturation, and Central Venous Oxygen Saturation). Respiratory [Impedance Respiration, Airway Gases (C02, 02, N20 and Anesthetic Agents), Spirometry, Gas Exchange] and N

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·March 19, 2014