12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
FDA 510(k)
FDA Class 1
·General Hospital
PERIOLASE ND:YAG DENTAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIMAX 2
FDA 510(k)
FDA Class 2
·Dental
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DIO·March 27, 2017
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DIO·May 23, 2017
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DIO·May 8, 2017
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code DIO·October 4, 2019
MEDICAL COMPRESSOR
FDA Adverse Event
Malfunction
·EKOM SPOL. S.R.O.·Product code BTI·April 5, 2011
MINIMAL ACCESS ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·April 5, 2013
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 12, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 8, 2011
Contour¿ next GEN Blood Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023