16 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OTE MPS 045 Multi-purpose Lens Care Solution
FDA 510(k)
FDA Class 2
·Ophthalmic
VULCAN
FDA UDI
Smith & Nephew, Inc.·03596010480521·KIT VULCAN GEN CONTL EUROPE
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151111·Resolve® Ceramic R018 UL 5-5 CS BC HK
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100510·Caddie, 5.5mm Screws
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151811·Resolve® Ceramic M018 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151121·Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5
POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
SYRINGE 50ML LL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·March 27, 2024
POLY-TAPE, 20 X 500MM
FDA Adverse Event
Injury
·XIROS·Product code JDR·December 6, 2011
GELFOAM STERILE SPONGE SIZE 100 X 6
FDA Adverse Event
Malfunction
·PFIZER INC.·Product code LMF·October 22, 2008
UNKNOWN - MAXON
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GAM·August 3, 2011
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
GALAXY G3 2.5MM X 5CM
FDA Adverse Event
Death
·MEDOS INTERNATIONAL SARL·Product code KRD·October 14, 2020
DigitalDiagnost C50 1.1
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·September 7, 2022
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024