BEUDAMED
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    HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Beaver Visitec Inter

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918172200·Non Reinforced Gown_35 gsm SMS w/ AS_XL_Non-Ste...

    Sharper Image

    FDA UDI
    Merchsource, LLC·00843479127003·

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00126541·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441664·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441671·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441657·

    HOWMEDICA OSTEONICS SHOULDER SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AT HOME DRUG TEST, MODEL 9078 T

    FDA 510(k)
    FDA Unclassified ·Unknown

    ASPEN SURGICAL

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, INC.·Product code FZZ·February 22, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Other ·STRYKER MEDICAL·Product code FNL·February 28, 2011

    INRATIO

    FDA Adverse Event
    Injury ·HEMOSENSE SJ·Product code JPA·March 11, 2008

    Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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

    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