103 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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aprevo Intervertebral Body Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
SprintRay Standard Denture Teeth - A2
FDA UDI
Sprintray, Inc.·00850039704369·SprintRay Standard Denture Teeth is a light-cur...
Greenwald Surgical Company, Inc.
FDA UDI
GRACE MANUFACTURING, INC.·10801334000851·Friedman-Otis bougie-a-boule. stainless steel
Conventional Lead Apron .5mm Xtra Large 25 X 40
FDA UDI
Flow X Ray Corporation·00843696123680·Conventional Lead Apron .5mm Xtra Large 25 X 40...
10M - General Purpose
FDA UDI
Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal
LEONE SPA
FDA UDI
LEONE SPA·08033707060994·BRACKETS 22 ANT
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112472·BARRON VACUUM TREPHINE 7.0MM
Surgical laser fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BLUE SKY BIO DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SMARTSITE 20MM VENTED VIAL ACCESS DEVICE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·February 26, 2021
SMARTSITE 20MM VENTED VIAL ACCESS DEVICE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 5, 2021
EEA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·February 12, 2021
SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·November 17, 2020
GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
FDA Adverse Event
Death
·W. L. GORE & ASSOCIATES, INC.·Product code PFV·October 20, 2020
BLAKE DRAIN UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GBX·February 9, 2021
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 21, 2014
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·June 27, 2013
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011
SMARTSITE 20MM VENTED VIAL ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·March 16, 2021
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025