8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Endotoxin Activity Assay (EAA)
FDA 510(k)
FDA Class 2
·Microbiology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515028104·Heiss Wound Spreader, Sharp,5x5
FREQUENCER
FDA 510(k)
FDA Class 2
·Anesthesiology
PASTURE, MODELS: F550, A520
FDA 510(k)
FDA Class 2
·General Hospital
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·July 28, 2011
RETAIN-SLEEVE LONG F/MATRIX 5.5
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·June 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026