12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BethaLoc® stem cementless HA
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOCORD
FDA UDI
Medos International Sàrl·10886705008742·ORTHOCORD Violet Braided Composite Suture OS-6 ...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113783·AIR INJECT CANNULA 25GA
TABLO(R) CARTRIDGE
FDA Adverse Event
Malfunction
·OUTSET MEDICAL, INC.·Product code FJK·November 18, 2022
Synapse 3D, Synapse 3D Base Tools v6.1
FDA 510(k)
FDA Class 2
·Radiology
DEPUY 1 GENTAMICIN BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
IMP,TSV,4.1MM,SBM,10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 26, 2019
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·August 10, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018