BEUDAMED
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    UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450182376·

    GUIDANT RETRIEVER DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASSURITY MRI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·October 15, 2025

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 3, 2024

    2.4MM VA LOCKING SCREW STARDRIVE 22MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·June 25, 2013

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HRS·July 15, 2013

    SIMPLEX TOBRAMYCIN 1 PK

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LOD·March 13, 2013

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·February 9, 2011

    COAGUCHEK S SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·February 8, 2008

    2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·December 24, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·July 30, 2015

    2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·October 24, 2015

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; 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

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018