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

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    ARTUS INFL A/B RG RT-PCR KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Pilot Spinal System

    FDA UDI
    Life Spine, Inc.·00190837051402·Tap, 8.5mm

    SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TCI-31 LIFELONG OVULATION TESTER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 14, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    UNKNOWN ORTHOPEDIATRICS LOCKING SCREW

    FDA Adverse Event
    Malfunction ·ORTHOPEDIATRICS, INC·Product code HWC·November 27, 2019

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·December 6, 2021

    GOBED+

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 15, 2013

    BARDPORT: IMPLANTED PORT 0710443 REV2 0602R

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code LJT·May 27, 2011

    HALL SURGICAL BUR GUARD, MEDIUM

    FDA Adverse Event
    Malfunction ·CONMED LINVATEC·Product code HWE·August 12, 2008

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EYB·July 2, 2024

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·February 28, 2022

    CR TIBIAL INSERT SZ 4, 9MM, SLOPE ++

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 30, 2024

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code EZL·July 8, 2022

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·January 15, 2021

    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 14, 2012

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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