BEUDAMED
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    VASCON NEUROPATH GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00520041·

    Freedom System Accessories

    FDA UDI
    Curonix LLC·00850051034208·PNS Wearable Accessory S/M

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809841671·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE ...

    PNS Wearable Accessory S/M

    FDA UDI
    STIMWAVE TECHNOLOGIES INCORPORATED·00818225021874·Externally worn transmitter for the Wearable An...

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124016·Modular Offset Stem 19mm x 100mm x 4mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690128038·Revision Offset Stem 19mm x 100mm x 4mm

    EASY GUIDE ELECTROSURGICAL ACCESS DEVICE

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

    ZYBIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARCHITECT CA19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·October 31, 2025

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·January 22, 2009

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·May 19, 2026

    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    ACF DETACHABLE TRIAL SPACER LORDOTIC 6MM

    FDA Adverse Event
    Injury ·SYNTHES JENNERSVILLE·Product code LXH·April 11, 2013

    HUDSON NEONATAL HEATED WIRE VENTILATOR CIRCUIT

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAI·February 28, 2011

    PEDISAT - CENTRAL VENOUS OXIMETRY CATHETER KIT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYG·May 21, 2008

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·May 1, 2026

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 23, 2012

    LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company

    FDA Recall
    Terminated ·Spinal Concepts, Inc·Product code KWQ·March 1, 2004