61 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code CKD·July 14, 2004
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code CKD·March 6, 2013
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
FDA Enforcement
Class II
·Terminated·C-RAD POSITIONING AB·July 21, 2021
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
FDA Recall
Terminated
·C-RAD POSITIONING AB Bredgrand 18 Uppsala Sweden·Product code IYE·August 6, 2020
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·August 8, 2006
Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810
FDA Recall
Terminated
·Lorad, A Hologic, Inc.·Product code MUE·February 28, 2008
C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only 5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.
FDA Recall
Terminated
·Camlog Usa·Product code NHA·August 28, 2013
CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
FDA Recall
Terminated
·iCAD, Inc.·Product code LNH·December 9, 2008
Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.
FDA Recall
Terminated
·Talladium Inc·Product code EIH·August 6, 2020
C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.
FDA Enforcement
Class II
·Terminated·Camlog Usa·September 25, 2013
Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.
FDA Enforcement
Class II
·Terminated·Talladium Inc·September 16, 2020
CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response.
FDA Recall
Terminated
·iCAD, Inc.·Product code LNH·December 9, 2008
Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
FDA Recall
Terminated
·Associates of Cape Cod, Inc.·Product code NQZ·August 17, 2022
Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.
FDA Recall
Terminated
·Product code IQO·July 27, 2012
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193
FDA Recall
Terminated
·Ivoclar Vivadent AG Benderer Strasse 2 Schaan Liechtenstein·Product code EIH·April 13, 2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN
FDA Recall
Terminated
·Ivoclar Vivadent AG Benderer Strasse 2 Schaan Liechtenstein·Product code EIH·April 13, 2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194
FDA Recall
Terminated
·Ivoclar Vivadent AG Benderer Strasse 2 Schaan Liechtenstein·Product code EIH·April 13, 2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686195
FDA Recall
Terminated
·Ivoclar Vivadent AG Benderer Strasse 2 Schaan Liechtenstein·Product code EIH·April 13, 2020
NPr FCZImp Crwn ASC CC RP CAD 1-25 s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77364
FDA Recall
Terminated
·Nobel Biocare Procera LLC·Product code NHA·March 29, 2021
NPr FCZImp Crwn ASC CC NP CAD 1-25 s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387
FDA Recall
Terminated
·Nobel Biocare Procera LLC·Product code NHA·March 29, 2021