BEUDAMED
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    MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BetaForce™

    FDA UDI
    Ortho Organizers, Inc.·00190707124694·BETAFORCE Beta³ Lengths 18x18 (10pk), 14" lengths

    BetaForce

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730022325·Beta3 Lengths 18x18 10 per pack, 14" lengths

    XIPHOS ZFUZE

    FDA UDI
    Difusion Technologies, Inc.·00853896008229·TLIF Spacer 24mm Long x 9mm Height

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967188850·Battalion, LLIF Trial, 0°, 24 mm Wide, 09 mm X ...

    MODIFICATION TO T-REX BIOPSY FORCEPS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·January 27, 2021

    DA VINCI ROBOTICS SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC.·Product code NAY·October 21, 2003

    UPSYLON

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTO·October 11, 2022

    NA

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NLM·March 8, 2013

    PRIMA ESTH CON ZI ABUT RD 5.0X1.5

    FDA Adverse Event
    Malfunction ·KEYSTONE DENTAL·Product code NHA·January 28, 2011

    FINELINE II

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·February 7, 2008

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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