BEUDAMED
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    AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007

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

    SCANLAN® Legacy Micro Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159033557·Legacy FRCP FH 1MM PTF DD 10"

    LINK Instruments - Rasps, compressors and broaches

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575293520·Orthopaedic prosthesis instrument, reusable - G...

    'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

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

    ANATOMIC TOTAL KNEE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UCSS SCREW SET

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MRW·June 4, 2009

    UCSS SCREW SET

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code HWC·June 4, 2009

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·January 31, 2023

    UCSS

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 2, 2016

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 14, 2013

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code GCJ·March 1, 2011

    MITY VAC

    FDA Adverse Event
    Injury ·COOPERSURGICAL, INC.·Product code HDB·February 25, 2008

    UCSS SCREW SET

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·January 3, 2011

    UCSS SCREW SET

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 23, 2020

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 15, 2026

    GUIDE, SURGICAL, INSTRUMENT

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code FZX·September 25, 2019

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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