14 results
·
20ms
·
Sources: EU EUDAMED, US FDA
NET-2000 MICROCURRENT STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
REMEL
FDA UDI
REMEL, INC.·00848838005794·Andrades Broth w/1% Rhamnose 20/PK
TruForm
FDA UDI
Rmo, Inc.·00885797099709·MX MLR BDS R/L SE ASIA ASST100
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450095072·
VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
FDA 510(k)
FDA Class 2
·Hematology
RESTORE
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·November 14, 2011
PROFEMUR(R) HIP STEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 10, 2010
ALIGN TO URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LTD·Product code FTL·April 11, 2013
EASYTRAK 3
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 15, 2011
HYPERFORM OCCLUSION BALLOON SYSTEM
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code MJN·June 11, 2008
EVOLUT FX VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 7, 2024
RESTORE ADVANCED
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·July 30, 2012
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026