BEUDAMED
    27 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01

    FDA Enforcement
    Class II ·Ongoing·Zimmer, Inc.·December 21, 2022

    NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02

    FDA Enforcement
    Class II ·Ongoing·Zimmer, Inc.·December 21, 2022

    NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02

    FDA Enforcement
    Class II ·Ongoing·Zimmer, Inc.·December 21, 2022

    NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

    FDA Enforcement
    Class II ·Ongoing·Zimmer, Inc.·December 21, 2022

    NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02

    FDA Enforcement
    Class II ·Ongoing·Zimmer, Inc.·December 21, 2022

    NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01

    FDA Enforcement
    Class II ·Ongoing·Zimmer, Inc.·December 21, 2022

    Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226

    FDA Enforcement
    Class II ·Ongoing·DePuy Orthopaedics, Inc.·March 29, 2023

    Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118

    FDA Enforcement
    Class II ·Ongoing·DePuy Orthopaedics, Inc.·March 29, 2023

    Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312

    FDA Enforcement
    Class II ·Ongoing·DePuy Orthopaedics, Inc.·March 29, 2023

    Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212

    FDA Enforcement
    Class II ·Ongoing·DePuy Orthopaedics, Inc.·March 29, 2023

    NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

    FDA Enforcement
    Class II ·Ongoing·Zimmer, Inc.·April 2, 2025

    Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03 MCGRAW SIGHTPATH MEDICAL 16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL 17570-05 CATARACT CENTURION FORT MADISON COMM HOS 19002-02 CATARACT BAPTIST HEALTH SURGERY CENTER 10560-14 CATARACT - NORTH CENTRAL 1 SIGHTPATH MED 16877-11 DR DAVID B LEACH CLEARVIEW SURGERY CENTE 19061-02 HOSLER UNIVERSITY SURGI CENTER 18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL 17469-02 GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI 18917-01 CATARACT 2 SURGERY CENTER OF THE TEMECUL 17115-06 DR SCZEPANSKI NORTH DAKOTA EYE CLINIC 17780-04 OPHTHALMIC TEXAS PRECISION SURGERY CENTE 2452-58 CATARACT BOLSA OUTPATIENT SURG CTR 19096-01 OPHTHALMIC EAST ALABAMA AMB SURGERY CENT 18023-04 OPHTHALMIC BRAINARD SURGERY CENTER 17039-13 EYE-Q COMPLETE CAT PAK VISION CARE SURG 5300-61 CATARACT WOODLAND MEM HOSP

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LLC·April 5, 2023

    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·September 25, 2024

    Regard Kit containing the Microtek decanter

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·August 28, 2024

    Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·May 3, 2023

    Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·November 22, 2023

    Regard, Item Number 830067009, custom cardiovascular procedure kit

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·April 14, 2021

    Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·May 3, 2023

    Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·May 3, 2023

    Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy.

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·May 3, 2023