BEUDAMED
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    REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00272131·

    Diamond Orthopedic, LLC

    FDA UDI
    DIAMOND ORTHOPEDIC, LLC·B551DMD2002723·3.0mm, Cannulated Screw, Self Drilling, Long T...

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20027230·3.0mm Cannulated Screw, Self-Drilling, Long Thr...

    Endo-Model Standard Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575432059·Hinge Knee Replacement Set,

    HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COOL-TEC ELECTRODES

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

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·March 13, 2013

    UNKNOWN DEPUY INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 17, 2011

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE-PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL·Product code HQL·February 26, 2008

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024