14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ENSEAL PTC TRIO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Mizzy Comfort Cushion
FDA UDI
Keystone Industries·H66860701651·Stac Pac Analgegia Mask Cushion/Backplate Child...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699388·Hex Key Ø1.25mm L23mm, Extra-Long
ERO SCAN OAE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
FDA 510(k)
FDA Class 1
·General Hospital
ADVIA CENTAUR XP HAV TOTAL (AHAVT)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOL·February 26, 2016
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 16, 2013
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 22, 2022
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 15, 2013
PFC SIGMA/OV DOME PAT 3 PEG, 32
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 25, 2011
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·July 3, 2008
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·August 26, 2013
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012