BEUDAMED
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    NITRATE SWAB-RAPID TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526159785·PROTECT.LEVA ANKLE SUPPORT GRAY III

    PC

    FDA UDI
    Allied Medical, LLC·00026072016978·FLWMTR O2 DISS FHT 8LPM

    VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STAT DL 9.5 FR. 34 CC. IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·June 4, 1998

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·October 17, 2012

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·May 8, 2014

    UNK DEPUY SZ4 14MM INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 10, 2010

    TRUE METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·August 14, 2023

    Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

    FDA Recall
    Terminated ·Nipro Diagnostics, Inc.·Product code NBW·February 25, 2013

    WALGREENS TRUE METRIX

    FDA Adverse Event
    Injury ·TRIVIDIA HEALTH, INC.·Product code NBW·August 3, 2023

    WALGREENS TRUE METRIX

    FDA Adverse Event
    Injury ·TRIVIDIA HEALTH, INC.·Product code NBW·August 3, 2023

    VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 20, 2016