BEUDAMED
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    NUMED HIGH PRESSURE PTA CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964152528·Endo Carry-on Procedure Kit contains Basin, VIA...

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023864·BAYONETTED ANGLED RING CURETTE

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023857·BAYONETTED OSTEOTOME - 1/4"

    INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

    FDA 510(k)
    FDA Class 2 ·Immunology

    ASCENT REV FEM STEM 20X150

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 11, 2025

    TORRENT IRRIGATION TUBING

    FDA Adverse Event
    Malfunction ·UNITED STATES ENDOSCOPY GROUP, INC.·Product code GCJ·March 14, 2013

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·March 3, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    ASCENT CLSD BOX PS FMRL LG L

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·January 23, 2025

    VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 40CM)

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSY·January 7, 2022

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·March 4, 1998

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·March 4, 1998

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018