BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    Dry DBM- A Putty

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUICKANCHOR PANACRYL

    FDA UDI
    DEPUY MITEK, LLC·10886705001996·Super QUICKANCHOR Plus Size 2 (5 metric) PANACR...

    Fluid Retention Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112854·VIDAURRI FLUID RETENTION WELL 8.7MM

    DEWIN

    FDA UDI
    DonneVie Medical Technology(Shanghai)Co.Ltd·16972962311634·Micromanipulation pipette is a disposable steri...

    CADD

    FDA UDI
    ICU MEDICAL, INC.·10610586035005·

    Stryker

    FDA UDI
    Provision·B504TQ59212121350·

    Color Cuff

    FDA UDI
    STRYKER CORPORATION·07613154599691·Disposable Tourniquet Cuff Single Bladder, Sing...

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825016494·Tourniquet Color Cuff Single Port, Single Bladd...

    POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ECG-6 SERIES ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 29, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 9, 2013

    Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002 SMI7010-7006 SMI7010-7007 SMI7010-7008 SMI7010-7010 SMI7010-7011 SMI7010-7012 SMI7010-7015 STR5921-018-136 STR5921-018-235 STR5921-024-135 STR5921-024-136 STR5921-024-146 STR5921-024-235 STR5921-030-135 STR5921-030-235 STR5921-034-135 STR5921-034-136 STR5921-034-235 STR5921-044-135 STR5921-044-136 STR5921-044-235 STR5921-212-135 ZIM60-7070-02 ZIM60-7070-03 ZIM60-7070-04 ZIM60-7070-05 ZIM60-7070-06 ZIM60-7070-07 ZIM60-7070-101 ZIM60-7070-102 ZIM60-7070-103 ZIM60-7070-104 ZIM60-7070-105 ZIM60-7070-106 ZIM60-7070-107 ZIM60-7075-006 ZIM60-7075-03 ZIM60-7075-04 ZIM60-7075-05 ZIM60-7075-06 ZIM60-7075-07 ZIM60-7075-101 ZIM60-7075-102 ZIM60-7075-103 ZIM60-7075-104 ZIM60-7075-106 ZIM60-7075-107 ZIM60-7080-102 and ZIM60-7080-103 A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code KCY·August 8, 2008

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021