10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
NERVE FINDER
FDA 510(k)
FDA Class 2
·Anesthesiology
MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
EMMa Electronic Monitoring Management
FDA 510(k)
FDA Class 2
·Cardiovascular
RAD-57 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·July 26, 2023
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·May 28, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 5, 2010
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Malfunction
·ACCESSCLOSURE, INC.·Product code MGB·November 30, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
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