BEUDAMED
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    NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT

    FDA 510(k)
    FDA Class 2 ·Dental

    Eclipse Vent Filter

    FDA UDI
    BLEEP, LLC·00850003157214·

    Osstell SmartPeg Type 81

    FDA UDI
    Osstell AB·09010522001851·ISQ Measurement Peg

    HOHMANN ELEVATOR RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896049413·HOHMANN ELEVATOR RETRACTOR

    THORLAKSON LOWER OCCLUSIVE CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896011571·THORLAKSON LOWER OCCLUSIVE CLAMP ANGLED TO SIDE...

    NITANIUM® SUPER ELASTIC ARCHWIRES

    FDA UDI
    Ortho Organizers, Inc.·00190707059934·.018 X .018 LOWER NITANIUM® SUPER ELASTIC PRO F...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450392652·

    Disposable Sterile Kit

    FDA UDI
    RESTORATION ROBOTICS, INC.·00850470007159·

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494462276·Bone Chisel Awl Square Handle Steel D 3.0mm, W...

    Monoblock Tibial Trial PS Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215042714·

    POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ALLURA XPER FD

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·March 18, 2026

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013

    CAPTIFLEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·September 19, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 17, 2011

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYF·September 10, 2020

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    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