103 results · 22ms · Sources: EU EUDAMED, 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