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    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

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

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025

    Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - H¿PATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT, GK1033, AME STANDARD KIT 21-023, GK1044, KE39830 COLE, GK1047, AME STANDARD KIT 22-003, GK1063, AME STANDARD KIT 22-022, GK1068, AME STANDARD KIT 22-027, GK1071, AME STANDARD KIT 22-030, GK1083, AME STANDARD KIT 22-045, GK1094, AME STANDARD KIT 23-015, GK1096, AME STANDARD KIT 23-017, GK1101, AME STANDARD KIT 23-033, GK131, LAP CHOLE PROCEDURE PACK, GK153, TOTAL 5mm SOLUTION KIT 11, GK168, 10mm ACCESS/LIGATION/RETRIEVAL PK, GK258, AME STANDARD KIT 44, GK260, STANDARD SET 360 Z, GK307, CHOLE KIT 1, GK308, CHOLE KIT 15, GK320, CHOLE KIT 24, GK358, CHOLE KIT 22, GK360, CHOLE KIT 18, GK363, CHOLE KIT 31, GK364, CHOLE KIT 30, GK365, CHOLE KIT 28, GK368, CHOLE KIT 33, GK401, TOTAL 5mm SOLUTION KIT 41, GK402, TOTAL 5mm SOLUTION KIT 42, GK736, LAP. CHOLECYST. CLIP, GK738, STANDARD SET 112 F, GK739, STANDARD SET 397 F, GK834, K100796, GK835, KIT AME 55003, GK837, KIT K86656, GK857, KIT CHOLECYSTECTOMIE LOBBES, GK858, KIT KE284, GK861, KIT VESICULE 11MM CHA, GK874, LAP CHOLE KIT Z-THREAD, GK877, LAP CHOL KIT 5, GK878, SSMC LAP, CHOLE, KIT NO.1, GK879, SSMC LAP, CHOLE, KIT NO. 2, GK891, LAP-GALLE-SET, GK895, KIT HERES LAP CHOL 5MM, GK905, GALLKIT TORSBY SJUKHUS, GK920, K57569, GK921, K57526, GK924, K65251, GK962, LAP CHOL BOOM, GK965, URO- VARIKOCELEN+LYMPHEKTOMIESET, GK969, KIT LAP CHOL TOORENVLIET, GK980, KE78892 LAP PROSTATECTOMY 2, GK983, KIT KE 111515, GK987, LAP. CHOLE-SET LKH MURTAL, GK988, LAPCHOLE KIT ERASME VERSION 4, GK992, K8056 - KIT COLE, GK993, K116634, GK998, GALLEKIT VOSS, JK001, OLYMPUS KIT 1 (2XCTF03,1XCA500), JK003, OLYMPUS KIT 3 (2XCFF05, 1XCA500), JK004, OLYMPUS KIT 4 (2XCTR05, 1XCA500), K0880, DR. THAMES-LAP CHOLE, K0924, DR. COMPTON'S LAP CHOLE PACK, K2212, DR. MILLER LAP CHOLE KIT, K2440, LAP CHOLE KIT, K2607, BORLAND GASTRIC SLEEVE, K2640, LAP CHOLE KIT, K2656, SOUTH SUNFLOWER LAP CHOLE KIT, K2703, DR. AZAR LAP CHOLE PACK, K2705, DRS.GIROD & INGRAM LAP CHOLE PACK, K2797, LAP CHOLE PROCEDURAL PACK 1, K2903, LAP CHOLE KIT, K2922, KIT CLIP APPLIER, K2924, CLIP KIT A, K2925, CLIP KIT F, K2926, CLIP KIT F, K2927, CLIP KIT B, K2928, LAP CHOLE KIT, K2929, LAP CHOLE KIT, K2933, AM MENAT KIT # 0001, K2934, AM MENAT KIT # 0002

    FDA Enforcement
    Class II ·Ongoing·Applied Medical Resources Corp·April 3, 2024