BEUDAMED
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    Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205003034·Luna Opal MB Mini .018 LL5 (-17°T +2°A)

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551111467·HALO, 1203-5 VEST SMALL, ACRYLIC LINER, 1211-1 ...

    COSMEDICO

    FDA UDI
    JW NORTH AMERICA, INC.·G6192111210·Ultraviolet tanning device

    RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS

    FDA 510(k)
    FDA Unclassified ·Unknown

    VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NOVUM IQ

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2025

    TROCHANTERIC NAIL KIT, TI 11X200MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 23, 2008

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 8, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 8, 2013

    DEKA MOTUS AZ

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 8, 2024

    NAVLOCK

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code OLO·February 9, 2024

    Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 35 mm, P/N 7211121, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HWC·August 21, 2007

    Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025