116 results
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16ms
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Sources: EU EUDAMED, US FDA
00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533 Femur CR POR SURF HDN FEM CO-NID EML, Rx, Sterile; 00597201534 Femur CR POR SURF HDN FEM CO-NID EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 28, 2013
65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR FEM SURF HDN HATCP CMR, Rx, Sterile; 65597201433 Femur CR POR FEM SURF HDN HATCP DML, Rx, Sterile; 65597201434 Femur CR POR FEM SURF HDN HATCP DMR, Rx, Sterile; 65597201533 Femur CR POR FEM SURF HDN HATCP EML, Rx, Sterile; 65597201534 Femur CR POR FEM SURF HDN HATCP EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 28, 2013
00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile; 00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx, Sterile; 00597001434 Femur CR PRC SURF HDN FEM CO-NID DMR Rx, Sterile; 00597001533 Femur CR PRC SURF HDN FEM CO-NID EML Rx, Sterile; 00597001534 Femur CR PRC SURF HDN FEM CO-NID EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 28, 2013
LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FEM SZ E-LT This device is indicated for patients with severe knee pain and disability
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx, Sterile; 00597201232 Femur CR POR SURF HDN FEM CO-NID BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 28, 2013
00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; 00597001231 Femur CR PRC SURF HDN FEM CO-NID BML, Rx, Sterile; 00597001232 Femur CR PRC SURF HDN FEM CO-NID BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 28, 2013
65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 28, 2013
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
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016
BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016
BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016
BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·December 28, 2016