BEUDAMED
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    Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACUFEX

    FDA UDI
    Smith & Nephew, Inc.·03596010527295·MTO TEARDROP PNCH LEFT DWN SWPT 10 DEG

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319722336·Saldhana Retractor 8-prong 5' x 2-3/8" (6cm x 1...

    BLUEPHASE STYLE

    FDA 510(k)
    FDA Class 2 ·Dental

    CH 2000 CARDIAC DIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOLOX DELTA HEAD 12/14 40X0

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·April 24, 2026

    G7 OSSEOTI 4 HOLE SHELL 54MM F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 24, 2026

    KARDIAMOBILE

    FDA Adverse Event
    Malfunction ·ALIVECOR·Product code DPS·January 24, 2022

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    MEDTRONIC

    FDA Adverse Event
    Injury ·MEDTRONIC INC.·Product code LGW·October 21, 2008

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

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

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 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

    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