45 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15, 8-I7504-COL-60 and 3-I7504-COL. Clinical chemistry reagent for the quantitative determination of iron in serum.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code JIY·November 16, 2009
SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 13, 2019
ADVIA Centaur Folate (FOL)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 2, 2018
Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy.
FDA Recall
Terminated
·Action Products Incorporated·Product code JAD·June 26, 2009
Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.
FDA Recall
Terminated
·Action Products Incorporated·Product code JAD·June 26, 2009
ADVIA Centaur¿ Folate (FOL)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 3, 2013
SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HRS·October 10, 2019
Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR ". Product is used as an orthopedic implant.
FDA Recall
Terminated
·Acumed LLC·Product code HWC·July 9, 2007
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CGN·November 30, 2018
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 21, 2013
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·January 2, 2019
Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·November 30, 2007
Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures during the normal healing process.
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·March 23, 2016
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code CGN·November 14, 2012
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·December 19, 2012
IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics·Product code CGN·November 6, 2013
IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics·January 1, 2014
IMx HAVAB Controls In Vitro Test
FDA Recall
Terminated
·Abbott Health Products, Inc.·Product code LOL·March 4, 2005
Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).
FDA Recall
Terminated
·Cardiac Science Corporation·Product code IOL·March 30, 2009