BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    Geistlich Mucograft®, Geistlich Mucograft® Seal

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517569066·CoRoent Ant TLIF Ti, 11x10x28mm 0°

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319707043·Joseph Nasal Saw 7-1/2" (18.8cm), straight

    ONE TOUCH PROFILE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 30, 2002

    RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    REVLOK FENESTRATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 8, 2021

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 16, 2021

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 7, 2016

    I-STAT 6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·September 28, 2021

    HALO360 ABLATION CATHETER

    FDA Adverse Event
    Other ·BARRX MEDICAL, INC·Product code GEI·October 6, 2008

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 27, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·August 8, 2011

    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·February 17, 2021

    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 Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    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

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 30-0025 35.0mm Acutrak 2¿ - 5.5 Screw 30-0025-S 35.0mm Acutrak 2¿ - 5.5 Screw 30-0027 40.0mm Acutrak 2¿ - 5.5 Screw 30-0027-S 40.0mm Acutrak 2¿ - 5.5 Screw 30-0029 45.0mm Acutrak 2¿ - 5.5 Screw 30-0029-S 45.0mm Acutrak 2¿ - 5.5 Screw 30-0031 50.0mm Acutrak 2¿ - 5.5 Screw 30-0031-S 50.0mm Acutrak 2¿ - 5.5 Screw 30-0084 55.0mm Acutrak 2¿ - 5.5 Screw 30-0084-S 55.0mm Acutrak 2¿ - 5.5 Screw 30-0085 60.0mm Acutrak 2¿ - 5.5 Screw 30-0085-S 60.0mm Acutrak 2¿ - 5.5 Screw 30-0620 20.0mm Acutrak 2¿ - 4.7 Screw 30-0620-S 20.0mm Acutrak 2¿ - 4.7 Screw 30-0622 22.0mm Acutrak 2¿ - 4.7 Screw 30-0622-S 22.0mm Acutrak 2¿ - 4.7 Screw 30-0624 24.0mm Acutrak 2¿ - 4.7 Screw 30-0624-S 24.0mm Acutrak 2¿ - 4.7 Screw 30-0626 26.0mm Acutrak 2¿ - 4.7 Screw 30-0626-S 26.0mm Acutrak 2¿ - 4.7 Screw 30-0628 28.0mm Acutrak 2¿ - 4.7 Screw 30-0628-S 28.0mm Acutrak 2¿ - 4.7 Screw 30-0630 30.0mm Acutrak 2¿ - 4.7 Screw 30-0630-S 30.0mm Acutrak 2¿ - 4.7 Screw 30-0635 35.0mm Acutrak 2¿ - 4.7 Screw 30-0635-S 35.0mm Acutrak 2¿ - 4.7 Screw 30-0640 40.0mm Acutrak 2¿ - 4.7 Screw 30-0640-S 40.0mm Acutrak 2¿ - 4.7 Screw 30-0645 45.0mm Acutrak 2¿ - 4.7 Screw 30-0645-S 45.0mm Acutrak 2¿ - 4.7 Screw 30-0650 50.0mm Acutrak 2¿ - 4.7 Screw 30-0650-S 50.0mm Acutrak 2¿ - 4.7 Screw 30-0740 40.0mm Acutrak 2¿ - 7.5 Screw 30-0740-S 40.0mm Acutrak 2¿ - 7.5 Screw 30-0745 45.0mm Acutrak 2¿ - 7.5 Screw 30-0745-S 45.0mm Acutrak 2¿ - 7.5 Screw 30-0750 50.0mm Acutrak 2¿ - 7.5 Screw 30-0750-S 50.0mm Acutrak 2¿ - 7.5 Screw 30-0755 55.0mm Acutrak 2¿ - 7.5 Screw 30-0755-S 55.0mm Acutrak 2¿ - 7.5 Screw 30-0760 60.0mm Acutrak 2¿ - 7.5 Screw 30-0760-S 60.0mm Acutrak 2¿ - 7.5 Screw 30-0770 70.0mm Acutrak 2¿ - 7.5 Screw 30-0770-S 70.0mm Acutrak 2¿ - 7.5 Screw 30-0775 75.0mm Acutrak 2¿ - 7.5 Screw 30-0775-S 75.0mm Acutrak 2¿ - 7.5 Screw 30-0780 80.0mm Acutrak 2¿ - 7.5 Screw 30-0780-S 80.0mm Acutrak 2¿ - 7.5 Screw 30-0785 85.0mm Acutrak 2¿ - 7.5 Screw 30-0785-S 85.0mm Acutrak 2¿ - 7.5 Screw 30-0790 90.0mm Acutrak 2¿ - 7.5 Screw 30-0790-S 90.0mm Acutrak 2¿ - 7.5 Screw 30-0795 95.0mm Acutrak 2¿ - 7.5 Screw 30-0795-S 95.0mm Acutrak 2¿ - 7.5 Screw 30-0800 100.0mm Acutrak 2¿ - 7.5 Screw 30-0800-S 100.0mm Acutrak 2¿ - 7.5 Screw 30-0805 105.0mm Acutrak 2¿ - 7.5 Screw 30-0805-S 105.0mm Acutrak 2¿ - 7.5 Screw 30-0810 110.0mm Acutrak 2¿ - 7.5 Screw 30-0810-S 110.0mm Acutrak 2¿ - 7.5 Screw 30-0815 115.0mm Acutrak 2¿ - 7.5 Screw 30-0815-S 115.0mm Acutrak 2¿ - 7.5 Screw 30-0820 120.0mm Acutrak 2¿ - 7.5 Screw Micro Acutrak 2 Part Number/Part Description: AT2-C08 through AT2-S34-S 8.0-34.0mm, Micro Acutrak 2¿ Bone Screw

    FDA Enforcement
    Class II ·Ongoing·Acumed LLC·January 4, 2023