BEUDAMED
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    TRUETOME

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694008990·2 x 3 Hole Compression T Plate

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989053265·PEERLESS 2NDMOL 6DEG LL NDX-2OTX022

    e-scope® ophthalmoscope LED 3.7 V, white,

    FDA UDI
    Rudolf Riester GmbH·04045396176980·The Riester ophthalmoscope is produced for the...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383505918·Gutta Percha Points is used to root canal filin...

    ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Integra®

    FDA UDI
    INTEGRA PAIN MANAGEMENT·10381780429586·Nerve Block Tray

    NA

    FDA UDI
    aap Implantate AG·04042409088803·APS Lag Screw, self-tapping, TL 22, L 115

    NA

    FDA UDI
    aap Implantate AG·04042409088810·APS Lag Screw, self-tapping, TL 22, L 115

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 26, 2019

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 31, 2020

    UNKNOWN NEXGEN KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·May 17, 2013

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·June 13, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·August 15, 2008

    NAVITOR TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code NPT·January 29, 2024

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Enforcement
    Class II ·Ongoing·Ithera Medical Gmbh·February 19, 2025

    BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000

    FDA Recall
    Terminated ·Abiomed, Inc.·Product code DSQ·August 19, 2003

    I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, EGG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esosophageal/Nasopharyngeal/Tymnpanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, and functional oxygen saturation (Sp0 2) and pulse rate via continuous monitoring , including monitoring during conditions of clinical patient motion or low perfusion. K120598 (Procare Monitor B40): The PROCARE Monitor 840 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor 840 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor 840 is not intended for use during MRI. The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympaiic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion. K130584 (Monitor B40): The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy. Product Quantity Distributed (Int) 16,061 (343 US, 15,718 OUS)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·October 11, 2013