58 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems Inc·July 1, 2015
The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems Inc·July 8, 2015
K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use
FDA Enforcement
Class II
·Terminated·Kamiya Biomedical Company, LLC·September 27, 2017
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
FDA Recall
Terminated
·Cook Inc.·Product code KYZ·December 19, 2017
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
FDA Enforcement
Class II
·Terminated·Cook Inc.·April 4, 2018
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
FDA Recall
Terminated
·Medtronic Inc.·Product code MDS·July 15, 2020
K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use
FDA Recall
Terminated
·Kamiya Biomedical Company, LLC·Product code JIX·July 19, 2017
ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents.
FDA Recall
Terminated
·Cardinal Health 303 dba Cardinal Health·Product code FRN·December 19, 2008
K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...".
FDA Recall
Terminated
·Kamiya Biomedical Company, LLC·Product code MGA·September 17, 2008
Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065
FDA Recall
Terminated
·Freedom Designs Inc·Product code IOR·May 14, 2007
MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZO·May 8, 2017
MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZP·May 8, 2017
MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZO·May 8, 2017
MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZP·May 8, 2017
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 55, Catalog Number LG-PR0855, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Number LG-PR0880, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 45, Catalog Number LG-PR0845, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 35, Catalog Number LG-PR0835, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 50, Catalog Number LG-PR0850, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 40, Catalog Number LG-PR0840, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007