BEUDAMED
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    NUMED GHOST II PTA CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964024960·The ENDO CARRY-ON Procedure Kit contains all of...

    SCANLAN® Legacy Micro Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159033526·Legacy FRCP FH 1MM PTF DD 7 1/8"

    LINK Instruments - Rasps, compressors and broaches

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575293469·Orthopaedic prosthesis instrument, reusable - G...

    ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN DEPUY PFC CR SZ 5 10MM TIB INSERT

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 14, 2013

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code MAF·March 1, 2011

    PFC SIGMA CRVD INSERT SZ4 10MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 22, 2008

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·January 22, 2026

    FISHER & PAYKEL HEALTHCARE

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

    BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JKA·July 3, 2019

    Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002

    FDA Recall
    Terminated ·Sybronendo·Product code EKM·October 27, 2009

    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·September 26, 2012

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024