36 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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Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.
FDA Enforcement
Class II
·Terminated·Ansell Sandel Medical Industries LLC·January 15, 2014
Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection.
FDA Enforcement
Class II
·Terminated·Skeletal Dynamics·December 17, 2014
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.
FDA Enforcement
Class II
·Terminated·Hans Pausch Rontgengeratebau Gmbh·June 7, 2017
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
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·April 1, 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 17¿ 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 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
BIOMET 3i CERTAIN 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 30¿ 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 CERTAIN 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 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