34 results
·
21ms
·
Sources: EU EUDAMED, US FDA
PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814671·GENUMEDI SILVER SIZE IV
CoRoent
FDA UDI
Nuvasive, Inc.·00887517573780·CoRoent Ant TLIF Ti, 10x12x40mm 4°
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664010485·BELLA STRONG 30-40 MM HG ARMSLEEVE KNIT WELT SI...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694008938·3 x 4 Hole Compression Y Plate
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383502238·Gutta Percha Points is used to root canal filin...
NIAGARA® Lateral Access System
FDA UDI
VB Spine LLC·10888857517264·Posterior Blade, Size 110 mm
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
FDA 510(k)
FDA Class 2
·Cardiovascular
MICRO-MAX, MODEL 319
FDA 510(k)
FDA Class 2
·Radiology
VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·January 18, 2023
QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
OXYGENRATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
CADD CASSETTE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·November 21, 2024
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 9, 2013
SYMBIQ SINGLE CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·August 27, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 20, 2011
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.
FDA Recall
Terminated
·Medtronic Vascular·Product code LOX·June 8, 2004