BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    MACS MODULAR ANTERIOR CONSTRUCT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Autosoft90™

    FDA UDI
    Unomedical A/S·05705244018334·Single use infusion set for subcutaneous infusi...

    QIAstat-Dx® Analyzer 1.0

    FDA UDI
    QIAGEN GmbH·04053228033936·Additional Catalog Numbers: 9002814 QIAstat-Dx ...

    DIALYZER

    FDA Adverse Event
    Malfunction ·ALTHIN MEDICAL, INC.·Product code FJI·July 14, 1994

    PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PERCUTANEOUS INTRODUCER, MODEL 10383-XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015

    0001222315-2025-002824

    FDA Adverse Event
    Injury ·STRAUMANN MANUFACTURING, INC.·Product code DZE·October 9, 2025

    AUTOSOFT 90

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·September 25, 2024

    MICRODEBRIDER 1898200T IGS M4

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014

    TRIDENT ALUMINA INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MRA·March 13, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·August 12, 2014

    CONGRUENCY PS FEM SZ 2+ R

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 16, 2011

    Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.

    FDA Enforcement
    Class II ·Terminated·Unomedical A/S·October 5, 2022

    Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.

    FDA Recall
    Open, Classified ·Unomedical A/S Aaholmvej·Product code FPA·July 21, 2022

    Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKX·September 12, 2005

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019