15 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EMPRESS DIRECT
FDA 510(k)
FDA Class 2
·Dental
Young
FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·00302730907018·Young Prophy Brush, Soft, Long Flat White Nylon...
LEONE SPA
FDA UDI
LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481120794·Attachment System, WP, Tissue Level, Blue Sky B...
Orthopedic manual surgical instrument
FDA UDI
BAUI BIOTECH CO. LTD.·04718005151899·Gun-type Pull-up Pliers
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 30, 2019
Phonak
FDA UDI
Phonak AG·07612847809284·Phonak Ambra SP (beige)
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
FDA 510(k)
FDA Class 2
·Immunology
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Dental
0.8% RESOLVE PANEL B FOR GEL
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·May 2, 2013
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·September 15, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
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