12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DURHAM; ADM. SET-LUER LOCK W/.22 MICRON FILTER
FDA 510(k)
FDA Class 2
·General Hospital
ORTHO
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750005277·ORTHO® HCV Version 3.0 ELISA Test System
Barco
FDA UDI
Barco NV·05415334002012·MDSC-2324 LED
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515239630·Joseph Nasal Knife, str, 24mm, pt, dbl edge, sm bl
RHYTHMIA MAPPING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
OSSIOfiber® Cannulated Trimmable Fixation Nail
FDA 510(k)
FDA Class 2
·Orthopedic
Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
INTELLAMAP ORION¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 16, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2014
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·January 30, 2019