13 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR
FDA 510(k)
FDA Class 1
·General Hospital
Reagent Kit
FDA UDI
Chromsystems Instruments + Chemicals GmbH·04250317538840·MassChrom® Biogenic Amines/Metabolites in urine...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694512·Titanium Base Abutment Internal Hex. SP H3mm No...
MULTI CARE THERAPEUTIC VIBRATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KSS·August 22, 2018
11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HSB·April 22, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 27, 2011
ACCU-CHEK ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 3, 2008
ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·August 8, 2018
UNKNOWN
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018