6 results
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6ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
FDA Enforcement
Class II
·Ongoing·Insulet Corporation·December 14, 2022
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes : (01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)00630414471235(10)99728138(17)20210130 (01)00630414471235(10)24043138(17)20210130 (01)00630414471235(10)32477138(17)20210130 Advia Centaur Systems HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10308993, UDI Codes: (01)00630414471228(10)64661A48(17)20201112 (01)00630414471228(10)81211A48(17)20201112 (01)00630414471228(10)91743A48(17)20201112 (01)00630414471228(10)22124A49(17)20201211 Product Usage: This product is intended to be used for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·October 28, 2020
HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope¿¿ System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC HER2 Image Analysis application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. The IHC HER2 Image Analysis application is intended for use as an accessory to the Dako HercepTest" to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. When used with the Dako HercepTest", it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN¿¿(Trastuzumab) treatment is being considered. Note: The IHC HER2 Image Analysis application is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER-2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the Dako HercepTest" to assure the validity of the IHC HER2 Image Analysis application assisted HER-2/neu score. The actual correlation of the Dako HercepTest" to Herceptin¿¿ clinical outcome has not been established. Manual Read of HER2 Digital Slides: The ScanScope¿¿ System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC HER2 Manual Read of Digital Slides application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. HER-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer. The IHC HER2 Manual Read of Digital Slides application is intended for use as an accessory to the Dako HercepTestT to aid the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. When used with the Dako HercepTestT, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN¿¿ (Trastuzumab) treatment is being considered. Note: The actual correlation of the Dako HercepTestT to Herceptin¿¿ clinical outcome has not been established. ER/PR Image Analysis: The ScanScope¿¿ XT System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded normal and neo
FDA Enforcement
Class II
·Terminated·Leica Biosystems Imaging, Inc.·March 19, 2014
Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent
FDA Enforcement
Class II
·Terminated·Cell Marque Corporation·June 7, 2017
Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
FDA Enforcement
Class II
·Terminated·Cell Marque Corporation·June 7, 2017
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TOTAL KNEE CDS-LF n. TOTAL SHOULDER CDS-LF o. TOTAL KNEE CDS-3 p. TOTAL HIP CDS-3 q. LOWER EXTREMITY CDS-LF r. TOTAL HIP-LF s. TOTAL HIP/KNEE CDS t. SPINE PROCEDURE u. OPEN HEART v. LAMI w. UPPER EXTREMITY CDS x. LOWER EXTREMITY CDS y. KNEE ARTHROSCOPY CDS z. KNEE ARTHROSCOPY CDS-LF aa. SHOULDER CDS-LF bb. PODIATRY CDS cc. KNEE ARTHROSCOPY CDS dd. SHOULDER ARTHROSCOPY CDS ee. ACL CDS ff. CRANIOTOMY CDS gg. TOTAL KNEE CDS hh. TOTAL KNEE ii. TOTAL HIP CDS jj. NEW LONDON TOTAL KNEE CDS kk. TRAUMA CDS-LF ll. TOTAL JOINT CDS mm. CRANIOTOMY CDS-1 nn. SHOULDER CDS-1 oo. SPINE CDS-1 pp. TOTAL KNEE CDS-1 qq. TOTAL HIP CDS-1 rr. LOWER EXTREMITY CDS-2 ss. HAND CDS-2 tt. KNEE ARTHROSCOPY CDS-2 uu. HAND CDS vv. BACK CDS ww. FRACTURE TABLE CDS xx. ORTHO OP CDS yy. ARTHROSCOPY CDS zz. ORTHO MINOR CDS aaa. TOTAL JOINT KNEE CDS bbb. TOTAL JOINT HIP CDS ccc. SHOULDER CDS-LF ddd. ZALE CRANIOTOMY CDS eee. ZALE TOTAL KNEE CDS fff. ZALE EXTREMITY CDS ggg. OPEN SHOULDER CDS hhh. LOWER EXTREMITY CDS iii. FHT TOTAL HIP jjj. FHT TOTAL KNEE RPLCMNT kkk. TOTAL HIP CDS lll. TOTAL KNEE CDS mmm. CCOC ACL-LF nnn. CCOC SPINAL FUSION ooo. CCOC MAJOR EXTREMITY ppp. EXTREMITY CDS qqq. PODIATRY CDS rrr. SHOULDER CDS sss. DISTAL LEG CDS ttt. HIP NAILING CDS uuu. SHOULDER CDS vvv. TOTAL HIP CDS www. UPPER EXTREMITY CDS xxx. BASIC ORTHO CDS yyy. TOTAL HIP PROCEDURE zzz. TOTAL JOINT CDS-LF aaaa. SHOULDER CDS-LF bbbb. HAND CDS-LF cccc. KNEE ARTHROSCOPY CDS-LF dddd. TOTAL JOINT eeee. UPPER EXTREMITY CDS ffff. LOWER EXTREMITY CDS gggg. GENERAL ORTHO CDS hhhh. ARTHROSCOPY CDS iiii. KNEE ARTHROSCOPY CDS jjjj. SHOULDER ARTHROSCOPY CDS kkkk. KNEE ARTHROSCOPY CDS llll. TOTAL ORTHO CDS mmmm. GROTH LOWER EXTREMITY CDS nnnn. HIP TOTAL PACK-ANTERIOR oooo. PRAIRIE STAR SPINE CDS pppp. 4TH FLOOR SHOULDER ARTHROSCOPY qqqq. FOOT & ANKLE CDS-LF rrrr. LAMI MICRODISC-LF ssss. HIP PINNING CDS-LF tttt. KNEE ARTHROSCOPY CDS-LF uuuu. UPPER EXTREMITY CDS-LF vvvv. SPINE CDS-LF wwww. SPINE CDS-LF xxxx. LOWER EXTREMITY/ELBOW CDS yyyy. HAND CDS zzzz. KNEE ARTHROSCOPY CDS aaaaa. SPINE CDS bbbbb. TOTAL HIP CDS ccccc. KNEE ARTHROSCOPY CDS ddddd. HAND CDS eeeee. TOTAL KNEE CDS-LF fffff. SPINE MODULE CDS ggggg. UPPER EXTREMITY CDS-LF hhhhh. TOTAL JOINT CDS iiiii. TOTAL JOINT CDS jjjjj. ORTHO TRAUMA CDS kkkkk. ACF CDS lllll. CRANIOTOMY CDS mmmmm. TOTAL JOINT CDS nnnnn. ARTHROSCOPY CDS ooooo. EXTREMITY CDS ppppp. PODIATRY CDS qqqqq. LAMINECTOMY CDS rrrrr. EXTREMITY CDS sssss. TOTAL KNEE CDS ttttt. TOTAL HIP CDS uuuuu. TOTAL KNEE vvvvv. ANTERIOR HIP wwwww. HAND WRIST FOREARM xxxxx. LOWER EXTREMITY yyyyy. TOTAL HIP zzzzz. TOTAL KNEE aaaaaa. SHOULDER ARTHROSCOPY bbbbbb. SHOULDER ARTHROSCOPY PK cccccc. LUMBAR LAMINECTOMY PACK dddddd. CRANIOTOMY PACK-LF eeeeee. OPEN SHOULDER PACK-LF ffffff. TOTAL HIP PACK-LF gggggg. TOTAL KNEE PACK-LF hhhhhh. SHOULDER ARTHROSCOPY PACK-LF iiiiii. EXTREMITY PACK jjjjjj. CLOSED HEART PEDS PACK kkkkkk. ORTHO MINOR PACK-LF llllll. FRACTURE TABLE PACK-LF mmmmmm. HAND - EDOC PACK-LF nnnnnn. FOOT LV - EDOC PACK-LF oooooo. SHOULDER - EDOC PACK-LF pppppp. FOOT ANKLE PACK-LF qqqqqq. OPEN HEART TRAY rrrrrr. SHOULDER PACK-LF ssssss. ROCKVILLE ASC EXTREMITY PACK tttttt. NEURO SPINE DRH PACK-LF uuuuuu. DRH ORTHOPEDIC I AND D PACK-LF vvvvvv. KNEE ARTHROSCOPY MIOSH PACK-LF wwwwww. HAND AND FOOT PACK-LF xxxxxx. SPINE BUNDLE PACK yyyyyy. MINOR ORTHOPEDIC PACK-LF zzzzzz. FEM POP PACK-LF aaaaaaa. LAMINECTOMY PACK-LF bbbbbbb. CRANIOTOMY PACK-LF ccccccc. MAJOR ORTHO PACK-LF ddddddd. HAND WRIST PACK-LF eeeeeee. TOSH PODIATRY PACK-LF fffffff. TOTAL HIP ARTHROPLASTY PACK-LF ggggggg. TOSH UPPER EXTREM MIOSH PK-LF hhhhhhh. OPEN HEART CHILDRENS PACK-LF iiiiiii. CRANIOTOMY PACK-LF jjjjjjj. SPINE HARPER PACK-LF kkkkkkk. CRANIOTOMY
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023