36 results
·
71ms
·
Sources: EU EUDAMED, US FDA
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
FDA Enforcement
Class II
·Terminated·Wako Life Sciences, Inc.·August 7, 2013
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
FDA Recall
Terminated
·Wako Life Sciences, Inc.·Product code DCF·April 30, 2013
OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter) manufactured by Olympus Life and Material Science Europa GmbH, Germany and distributed by Olympus America, Inc., 3131 W. Royal Ln., Irving, TX 75063.
FDA Recall
Terminated
·Olympus America, Inc·Product code JQP·November 18, 2005
Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.
FDA Recall
Terminated
·PerkinElmer LIfe Sciences Inc·Product code JJT·January 8, 2003
Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.
FDA Recall
Terminated
·PerkinElmer Life Sciences Inc·Product code JLJ·June 27, 2003
life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium Sulfur Dioxide, OEM P/N: 9146-001, voltage 12V, 7.5 amps, Mfg for Battery Zone, Inc ; Mfg by Nordix, Inc.
FDA Recall
Terminated
·BatteryZone, Inc.·Product code MKJ·August 24, 2007
life+cel, Replacement battery for Cardiac Science FirstSave Survivalink,Lithium Sulfur Dioxide, Voltage 12V, 7.5 Amps.,OEM P/N: 9141-001,Mfg for Battery Zone, Inc; Mfg by Nordix, Inc.
FDA Recall
Terminated
·BatteryZone, Inc.·Product code MKJ·August 24, 2007
MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) Roche Diagnostics Operations, Inc. An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LXG·July 21, 2011
MagNA Pure LC 1.0 (software version 3.0.11). Roche Diagnostics Operations, Inc. An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LXG·July 21, 2011
Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000
FDA Recall
Terminated
·Perkin Elmer Life and Analytical Sciences Inc·Product code JIA·January 9, 2004
Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000
FDA Recall
Terminated
·Perkin Elmer Life and Analytical Sciences Inc·Product code JIA·January 9, 2004
Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Luer-Lok" connector Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code KGN·March 13, 2015
Coupler System II Mizuho Orthopedic Systems, Inc. Union City, CA 94587 The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield clamp or the radiolucent or aluminum skull clamp referred to as the DORO which is manufactured by pro med instruments Inc.
FDA Recall
Terminated
·Mizuho Orthopedic Systems Inc·Product code FWZ·February 27, 2012
MPS Medical Product Service GmbH
Authorized representative
🇩🇪 Germany·35 Manufacturers·1959 Devices
Medica, medicinska zastopstva, trgovina, marketing in posredovanje, d.o.o.
Importer
🇸🇮 Slovenia·6 Manufacturers
ADMED - A.MŁOT ADAM MŁOT
Importer
🇵🇱 Poland·7 Manufacturers
QbD RepS BV
Authorized representative
🇧🇪 Belgium·86 Manufacturers·1555 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
mdi Europa GmbH
Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices
MedEnvoy Global BV
Authorized representative
🇳🇱 Netherlands·143 Manufacturers·2306 Devices