BEUDAMED
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    REPROCESSED STRYKER ARTHROSCOPIC SHAVERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDRAD® Veris™ 8600 Vital Signs Monitor

    FDA UDI
    BAYER MEDICAL CARE INC.·00616258009629·"PROBE, PULSE OX, GRIP, MEDIUM, 2M, VERIS (ASSE...

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040133323·Zirlux TR B4 98x22mm

    PERFORMATRAK

    FDA UDI
    Respironics, Inc.·00606959007598·Performatrak Mask with Headgear, Disposable, In...

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033435908·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361011880·PedFuse Respond, SLD, 5.0mm x 35mm

    BRAUN PRECISION SENSOR PRO, MODEL BP 2590

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERLOK / HA COPELAND RESURFACING HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TI TITAMAX IMPLANT (4.1)3.75X9

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·July 5, 2018

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·January 14, 2011

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·March 20, 2013

    DEPUY ASR FEM IMPLANT SZ 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Injury ·BAYER HEALTHCARE, LLC·Product code NBW·March 11, 2008

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. Intended use: Cutting Bones

    FDA Recall
    Terminated ·Acumed LLC·Product code HRS·April 14, 2010

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015