17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALPHA-DENT
FDA 510(k)
FDA Class 2
·Dental
Bioseal Inc.
FDA UDI
BIOSEAL·00630094194011·Winged Prep Sponge
OPTICS ONE
FDA UDI
MEDICAL TECHNIQUE, INC.·00815384021608·Leica/Wild Microscope Drape 42 x 120
OPTICS ONE
FDA UDI
MEDICAL TECHNIQUE, INC.·00815384021097·Zeiss OpMi Microscope Drape 42 x 120
SpiritMB
FDA UDI
ORMCO CORPORATION·00889989006971·ID D - Twin - Upper-Right Central - Blue
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981195328·Interbody, 9mm x 40mm x 12mm, 0 deg
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981203313·Interbody, 9mm x 40mm x 12mm, 0 deg
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955937118·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955939457·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938283·Percutaneous Transluminal Angioplasty Balloon C...
EPIC 10
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
FDA 510(k)
FDA Class 1
·Microbiology
V.A.C. THERAPY
FDA Adverse Event
Injury
·KCI USA INC.·Product code OMP·June 19, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
ACCURUS 800CS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 22, 2010
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020