BEUDAMED
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    MEDLINE ELECTRONIC POSITIONING CHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450029305·

    LIFEPAK® 15 monitor/defibrillator

    FDA UDI
    PHYSIO-CONTROL, INC.·00883873872024·15AAEBABBBBBAAAAAAAAAAAFLP15 MONITOR/DEFIB

    QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 20, 2026

    QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 8, 2025

    IVC TWO MEDIUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MODIFICATION TO EBI SPINELINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEALING UNIT FROM 5MM TROCARS

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015

    REDUCING CONVERTER 10/12MM TO 5MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 2, 2026

    LIGHT ADJUSTABLE LENS (LAL)

    FDA Adverse Event
    Injury ·RXSIGHT, INC.·Product code PZK·August 25, 2021

    DEXTRUS 4137

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·March 13, 2013

    ACCU-CHEK® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 27, 2011

    THERA-I DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·February 7, 2008

    The product is battery powered toothbrush. Spinbrush Pro Whitening Medium battery operated toothbrush, UPC 7 66878 00193 7.

    FDA Recall
    Terminated ·Proctor & Gamble Co·Product code JEQ·November 11, 2004

    Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014

    Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021