9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
FRASER HARLAKE DENTAL ANTI-POLUTION SYS
FDA 510(k)
FDA Class 2
·Anesthesiology
YASARGIL PERM MINI-CLIP SLT-CVD 4.7MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code HCH·February 19, 2014
POWDERED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
IMRI 1.5T AND IMRI 3T S
FDA 510(k)
FDA Class 2
·Radiology
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 27, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 15, 2012
UNKNOWN DEPUY CEMENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LOD·September 8, 2010
Brand Name: Canturio Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona Personalized Knee System.
FDA Recall
Open, Classified
·Canary Medical, Inc.·Product code QPP·May 2, 2025
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015