BEUDAMED
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    RENOVOCATH RC120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Biogel

    FDA UDI
    Bosma Enterprises·10818634024005·Biogel PI UltraTouch Surgical 7.5 - 50 Pair/Box

    Sterile ACIF PEEK

    FDA UDI
    Tyber Medical, LLC·M6958101411750·ACIF - 14mm x 11mm x 7.5 deg PEEK Curved

    FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MPACT FLAT PE HC LINER Ø40/G

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 11, 2022

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 3, 2014

    UNK DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 3, 2013

    IAB : 8 FR - 40 CC FOS

    FDA Adverse Event
    Injury ·ARROW INTERNATIONAL INC·Product code DSP·June 22, 2011

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; 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

    Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018