BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps¿ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·July 24, 2013

    Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE, Item 800003011, Lot # 82497. 6) Regard, SHOULDER ARTHRO, Item 800075010, Lot # 82490. 7) Regard, CERVICAL, Item 800058007, Lot # 82592. 8) Regard, ARTHROSCOPY, Item 800027008, Lot # 82582. 9) Regard, MAJOR SURGERY, Item 800013010, Lot # 82844. 10) Regard, GENERAL SURGERY, Item 800057012, Lot # 82832. 11) Regard, SEPTO SINUS ENDO, Item 800024006, Lot # 82876. 12) Regard, MINOR FMOL-LADY OF THE LAKE, Item 800019009, Lot # 82893. 13) Regard, KNEE ARTHRO, Item 800072009, Lot # 83058. 14) Regard, LAP, Item 800096005, Lot # 83139. 15) Regard, KNEE ARTHROSCOPY, Item 800121, Lot # 83251. 16) Regard, CYSTOSCOPY, Item 800093007, Lot # 83138. 17) Regard, LAP CHOLE, Item 800035007, Lot # 83257. 18) Regard, PERIPHERAL VASCULAR, Item 800007011, Lot # 83106. 19) Regard, PACEMAKER, Item 800083006, Lot # 82886. 20) Regard, I&D, Item 800056005, Lot # 83135. 21) Regard, HEAD & NECK, Item 800068010, Lot # 83050. 22) Regard, ROBOTICS, Item 800103007, Lot # 83264. 23) Regard, MAJOR EAR, Item 800070010, Lot # 82879. 24) Regard, ORTHO EXTREMITY, Item 800042009, Lot # 83383. 25) Regard, CRANIOTOMY, Item 800025015, Lot # 83271. 26) Regard, MINOR ORTHO, Item 800020007, Lot # 83583. 27) Regard, VATS, Item 800118001, Lot # 83421. 28) Regard, ARTHROSCOPY, Item 800027008, Lot # 83560. 29) Regard, OPEN HEART, Item 800023010, Lot # 83273. 30) Regard, PERIPHERAL VASCULAR, Item 800018011, Lot # 83575. 31) Regard, GENERAL PROCEDURE, Item 800000008, Lot # 83576. 32) Regard, DR WHITE OPEN HRT A&B, Item 800045012, Lot # 82847. 33) Regard, NEURO, Item 800008008, Lot # 83598. 34) Regard, LAPAROSCOPY, Item 880320008, Lot # 82472. 35) Regard, PACEMAKER, Item 880074023, Lot # 82417. 36) Regard, THYROID, Item 880425002, Lot # 82389. 37) Regard, LAPAROSCOPY, Item 880350012, Lot # 82473. 38) Regard, CHEST, Item 880373005, Lot # 82427. 39) Regard, BASIC CATARACT, Item 880348006, Lot # 82501. 40) Regard, CCOR HAND, Item 880337009, Lot # 82496. 41) Regard, CRANIOTOMY, Item 880396004, Lot # 82507. 42) Regard, TUR CYSTO, Item 880357006, Lot # 82574. 43) Regard, TOTAL HIP, Item 880266, Lot # 82478. 44) Regard, DAVINCI, Item 880132021, Lot # 82469. 45) Regard, KNEE ARTHROSCOPY, Item 880368, Lot # 82485. 46) Regard, UROLOGY, Item 880306010, Lot # 82584. 47) Regard, MINOR BREAST, Item 880195017, Lot # 82588. 48) Regard, LABOR & DELIVERY, Item 880081018, Lot # 82600. 49) Regard, PELVIC PROCEDURE, Item 880214016, Lot # 82597. 50) Regard, CCOR MINOR, Item 880336010, Lot # 82593. 51) Regard, YOUNG LUMBAR, Item 880432005, Lot # 82594. 52) Regard, PACEMAKER, Item 880418003, Lot # 82606. 53) Regard, LOCAL, Item 880087014, Lot # 82828. 54) Regard, COLON LITHOTOMY, Item 880395002, Lot # 82825. 55) Regard, EYE, Item 880099029, Lot # 82882. 56) Regard, FESS, Item 880404001, Lot # 83033. 57) Regard, CYSTO, Item 880312009, Lot # 82880. 58) Regard, EXTREMITY PACK, Item 880167018, Lot # 82887. 59) Regard, PHERIPHERAL VASC, Item 880077, Lot # 83048. 60) Regard, T & A, Item 880423002, Lot # 83073. 61) Regard, C CABG A & B, Item 880080, Lot # 83042. 62) Regard, DR MARBARGER, Item 880079011, Lot # 83124. 63) Regard, MPR LOCAL, Item 880360006, Lot # 83133. 64) Regard, KNEE ARTHROSCOPY, Item 880268, Lot # 83095. 65) Regard, MINOR PROCEDURE, Item 880261009, Lot # 83132. 66) Regard, EXTREMITY, Item 880262009, Lot # 83071. 67) Regard, LAPAROSCOPY, Item 880102018, Lot # 83238. 68) Regard, GENERAL LAPAROSCOPY, Item 880405002, Lot # 83254. 69) Regard, MAJOR PROCEDURE, Item 880270008, Lot # 83240. 70) Regard, YOUNG LUMBAR, Item 880432005, Lot # 83232. 71) Regard, MINOR LITHOTOMY, Item 88

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·January 6, 2021

    Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ00/0-R

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

    FDA Enforcement
    Class II ·Terminated·Med-Hot Thermal Imaging, Inc.·May 17, 2017

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·October 10, 2018

    AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.

    FDA Enforcement
    Class II ·Terminated·Vision Rt Inc·January 14, 2015

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

    FDA Enforcement
    Class II ·Terminated·Vision Rt Inc·December 3, 2014

    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018