BEUDAMED
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    Playboy 3 Contour Condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517286734·CoRoent® XL-CTW, 14x22x50mm

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517297754·CoRoent® XLK, 14x18x50mm

    InCompass®

    FDA UDI
    ZIMMER SPINE, INC.·00889024401532·

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221049025·Unitek(TM) Permachrome Standard Stainless Steel...

    MIROCAM CAPSULE ENDOSCOPE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SILICONE IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·December 14, 2017

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78821145000201·EXPERIENCE Mini MBT 018/LR5-17T 2A

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78821145000101·EXPERIENCE Mini ROTH 018/LR5-22T-1A 4D

    Vu aPod™ - L

    FDA UDI
    Seaspine Orthopedics Corporation·10889981046293·LATERAL IMPLANT, WIDE, STANDARD, 14mm X 23mm X ...

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

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021

    IKARIA

    FDA Adverse Event
    Malfunction ·IKARIA·Product code MRN·August 9, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 8, 2013

    Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

    FDA Enforcement
    Class II ·Ongoing·Abbott·April 30, 2025

    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

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    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