52 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code LPS·November 30, 2018
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·January 2, 2019
N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·March 1, 2017
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·June 26, 2013
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LPS·April 1, 2013
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·July 9, 2014
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code LPS·June 25, 2013
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
FDA Enforcement
Class III
·Terminated·CooperSurgical, Inc.·October 14, 2015
N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LPS·January 11, 2017
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.
FDA Enforcement
Class I
·Terminated·Acist Medical Systems·March 10, 2021
ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.
FDA Recall
Terminated
·Acrymed Incorporated·Product code FRO·June 30, 2008
Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads "CATCH Catch Inc., Bothell, WA 98011 HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test Kit, Manufactured at Intersect Systems, Inc., Longview, WA 98632". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1 HCY A (28mL), Homocysteine Reagent R2 HCY R2 (13.5 mL), Homocysteine HCY C (2.8 mL), Homocysteine 0.0 umol/L (2mL) and Homocysteine 27.0 umol/L (2mL). The second brand name Equal the label reads "EQual DIAGNOSTICS FOR IN VITRO DIAGNOSTIC USE ONLY HOMOCYSTEINE 3-Part Kit w/calibrators, Catalog Number E02-058-03, Equal Diagnostic, Exton, PA 19341". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1, Homocysteine Reagent R2, Homocysteine Reagent R3, Homocysteine Calibrator 0.0 umol/L and Homocysteine Calibrator 27.0 umol/L. All individual kits are packaged into individual boxes and then packaged into 1 box. Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in serum and plasma.
FDA Recall
Terminated
·Catch Incorporated·Product code LPS·January 18, 2007
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code FMF·October 20, 2017
GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX UPGRADE, 1.5 HDX, 1.5 HDX ECHOSPEED 16 CH, 1.5 HDX ECHOSPEED 8 CHANNEL, 1.5 HDXT, 1.5 HDXT-16 , 1.5 LX TO HDX 16C FORKLIFT UPG, 1.5 LX TO HDX 8C FORKLIFT UPG, 1.5 T UPGRADE TO HDX, 1.5EXCIT TO HDXT UPG, 1.5T HDX 16 CHANNEL, 1.5T 16CH UPG, 1.5T 6 CH HDX , UPGRADE, 1.5T 8CH HDXT TO 16CH HDXT UPG, 1.5T CRM LX TO HDX UPG, 1.5T ES HDX W/ONCOLOGY PACK, 1.5T EXC.TO HDX UPG, 1.5T EXC.TO HDXT UPG, 1.5T EXCITE HD TO HDX UPG, 1.5T EXCITE TO HDX UPG, 1.5T EXCITE TO HDX UPG, 1.5T EXCITE TO HDX UPG. W/ACGD, 1.5T EXCITE TO HDXT UPG, 1.5T EXCITE TO HDXT UPGRADE, 1.5T EX-HDX, 1.5T EX-HDXTWIN, 1.5T HD ES/HS MOBILE, 1.5T HD TO HDX UPG. 1.5T HD TO HDX UPGRADE, 1.5T HD TO HDXT UPG, 1.5T HD TO HDXT UPGRADE 1.5T HDI,1.5T HDI 16CH FIXED, 1.5T HDI 8CH FIXED, 1.5T HDI ECHOSPEED 1.5T HDI ECHOSPEED 8 CHANNEL, 1.5T HDI ECHOSPEED 8 CHANNEL 1.5T HDI ECHOSPEED 8 CHANNEL., 1.5T HDI ECHOSPEED 8 CHANNEL, 1.5T HDI ECHOSPEED 8 CHAN¿SO2762285, 1.5T HDI ECHOSPEED 8CH, 1.5T HDI ECHOSPEED MOBILE, 1.5T HDI ECSHOSPEED 8CH, 1.5T HDI TO HDXT UPGRADE, 1.5T HDX, 1.5T HDX - MEIRAV (BREAST), 1.5T HDX 8CM 1.5T HDX ECHOSPD 16, 1.5T HDX ECHOSPEED, 1.5T HDX ECHOSPEED 1.5T HDX ECHOSPEED 16, 1.5T HDX ECHOSPEED 16 CHANNEL, 1.5T HDX ECHOSPEED 16 CHANNEL, 1.5T HDX ECHOSPEED 16 CHANNELS, 1.5T HDX ECHOSPEED 16CH¿SO2659508, 1.5T HDX ECHOSPEED 16CH-SO2718893, 1.5T HDX ECHOSPEED 32 CHANNEL, 1.5T HDX ECHOSPEED 8 CH, 1.5T HDX ECHOSPEED 8 CHANNEL, 1.5T HDX ECHOSPEED MOBILE 1.5T HDX ECHOSPEED MRI, 1.5T HDX ES, 1.5T HDX ES 16, 1.5T HDX TWINSPEED, 1.5T HDX TWINSPEED 16 CHANNEL, 1.5T HDXT 1.5T HDXT 16CH,1.5T HDXT 16CH CXK4, 1.5T HDXT 16CH ES FIXED 1.5T HDXT 8 CH, 1.5T HDXT 8CH ES FIXED, 1.5T HDXT 8CH UP, 1.5T HDXT ECHOSPEE, 1.5T HDXT ECHOSPEED, 1.5T HDXT ECHOSPEED 16 CH 1.5T HDXT ECHOSPEED 16 CHAN, 1.5T HDXT ECHOSPEED 16 CHANNEL 1.5T HDXT ECHOSPEED 8, 1.5T HDXT ECHOSPEED 8 CHANN, 1.5T HDXT ECHOSPEED 8 CHANNEL, 1.5T HDXT ECHOSPEED 8 CHANNEL , 1.5T HDXT ECHOSPEED 8_CHANNEL, 1.5T HDXT ECHOSPEED MOBILE, 1.5T HDXT ES 8 CH, 1.5T HDXT GS, 1.5T HDXT TWIN, 1.5T HDXT TWINSPEE, 1.5T HDXT TWINSPEED 16 CHAN,1.5T HDXT UPG, 1.5T HDXTID, 1.5T LX HDX, 1.5T LX TO 16 CH HDXT UPG, 1.5T LX TO 16 CHAN, 1.5T LX TO 16 CHANNEL HDX UPG, 1.5T LX TO 16 CHANNEL HDX UPG, 1.5T LX TO 16 CHANNEL HDX UPGRADE, 1.5T LX TO 16 CHANNEL HDXT, 1.5T LX TO 16 CHANNEL HDXT UPG, 1.5T LX TO 16CHANNEL HDX U/G2777896, 1.5T LX TO 8 CH HDX UPG, 1.5T LX TO 8 CH HDXT UPG, 1.5T LX TO 8 CHANNEL HDX UP, 1.5T LX TO 8 CHANNEL HDX UPG, 1.5T LX TO 8 CHANNEL HDX UPG, 1.5T LX TO 8 CHANNEL HDX UPG.827015, 1.5T LX TO 8 CHANNEL HDXT UPG, 1.5T LX TO 8 CHANNEL HDXT UPGRADE, 1.5T LX TO HDXT 1.5T NON LCC4X5X TO HDXT UPGD, 1.5T NON-LCC LX/HRZ 5.5 TO 1.5T HDX, 1.5T SIGNA HDX UPG, 1.5T SIGNA HDXT, 1.5TEXCITE TO HDX UPG W/O A, 1.5TEXCITE TO HDX UPG W/O ACGD, 1.5TNONLCC LXHZ TO HDXT UPG, 1.5TNONLCC LXHZ TO HDXUPGW/ACD, 1.5TNONLCC4X5X TO HDXUPGW/OACD, 1.5TNONLCCLXHZ TO HDXUPGW/O ACD, 1¿5T 8CH HDXT MRI, 1¿5T HDXT, 1¿5T HDXT MRI, 1-5T CRM LX TO HDX , G.W/OACGD, 1-5T CRM LX TO HDXT UPG, 1-5T EXCITE TO 15T EXCITE TO HDX UPG, 1-5T HDI ECHOSPEED 16 CHANNEL, 15T HDI ECHOSPEED 8 CHANNEL, 1-5T HDX ECHOSPEED 16 CHANN, 15T HDX ECHOSPEED 16 CHANNEL, 15T HDX ECHOSPEED 8 CHANNEL, 15T HDX ECHOSPEED MOBILE, 1-5T HDX ECHOSPEED MOBILE, 1-5T HDX ECHOSPEED TRANSPORT, 1-5T HDX TWINSPEED 8 CHANNEL, 1-5T HDXT ECHOSPEED 16, 1-5T HDXT ECHOSPEED 16 CHAN, 1-5T HDXT ECHOSPEED 16 CHAN-HD16.0, 1-5T HDXT ECHOSPEED 16 CHANNEL, 1-5T HDXT ECHOSPEED 16 CHANNEL, 1-5T HDXT ECHOSPEED 16 UPGRADE, 1-5T HDXT ECHOSPEED 8 CHANN, 15T HDXT ECHOSPEED 8 CHANNEL, 1-5T HDXT ECHOSPEED MOBILE, 1-5T HDXT ECHOSPEED RELOCATABLE, 1-5T LX TO 16 CHANNEL HDX UPG, 1-5T LX TO 16 CHANNEL HDXT, 1-5T LX TO 8 CHANNEL HDXT U, 1-5T LX TO
FDA Enforcement
Class II
·Terminated·GE Medical Systems, LLC·October 24, 2018
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2013
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·March 20, 2013
SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·February 5, 2020
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi. Whole body magnetic resonance diagnostic imaging scanners.
FDA Enforcement
Class II
·Terminated·GE Healthcare·August 12, 2015
Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155
FDA Recall
Terminated
·Apple Medical Corporation·Product code HGI·March 10, 2006
Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034
FDA Recall
Terminated
·Aesculap Inc·Product code HCI·November 1, 2007