BEUDAMED
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    Longeviti PMMA Static Cranial Implant

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010605061·MTO BULLET ACL ECCENTRIC 12MM

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383514521·"An absorbent paper points is an endodontic pap...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106160·Trial, 26 x 16mm, 8 Degree, Tapered, Straight

    THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·October 23, 2008

    UNK MAMMARY IMPLANT

    FDA Adverse Event
    Injury ·UNKNOWN MANUFACTURER·Product code FWM·August 10, 2011

    CURRENT ACCEL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.

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

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025