12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AUTOMATED 8400 BLOOD CELL SEPARATOR
FDA 510(k)
FDA Unclassified
·Unknown
Two Striper
FDA UDI
ABRASIVE TECHNOLOGY, INC.·B868C8310041·Dental Root Canal Post
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310040·Probe, 1.5 inch Ball, Lenke, Straight, Black
NA
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024376045·
SYVA EMIT II PLUS AMPHETAMINES ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FLOW MED 160
FDA 510(k)
FDA Class 2
·General Hospital
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
FDA 510(k)
FDA Class 2
·Immunology
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·February 22, 2019
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LZG·May 23, 2014
ENDOCLIP III 5MM APPLIER WITH HEMOSTAY CLIP
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code FZP·November 2, 2012
ATLAS II PLUS DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA Enforcement
Class II
·Ongoing·Isopure Corp·July 20, 2022