12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOLOC 2.0/2.4 PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Amara View
FDA UDI
Respironics, Inc.·00606959009332·mask cushion
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 8, 2023
THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
EMIT 2000 VANCOMYCIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
COMPR 12MM IM HMRL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·April 1, 2019
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 2, 2013
CORAIL2 STD SIZE 12
FDA Adverse Event
Injury
·DEPUY FRANCE SAS·Product code KWA·September 15, 2014
CBCII BLOOD CONSERVATION KIT W/1/8 INCH ROUND PVC
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS PUERTO RICO·Product code CAC·April 19, 2011
Merit Medical systems, Inc, Convenience Kit REF/CAT no.: K09-07692 REVISION A , CUSTOM KIT
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code MDM·September 29, 2009
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018