16 results
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20ms
·
Sources: EU EUDAMED, US FDA
PLATELET AGGREGATION REAGENTS
FDA 510(k)
FDA Class 2
·Hematology
Sphero Attachments
FDA UDI
Preat Corporation·00842092110812·Sphero Reconstruction Kit 2.5mm Ø
TruForm
FDA UDI
Rmo, Inc.·00885797099662·MAX MOLAR BDS PEDO ASST 100
TensCare
FDA UDI
TENSCARE LIMITED·05033435136490·The Nouri Digital Electric Breast Pump is a pow...
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·00840117408784·
THD PressKit
FDA UDI
THD SPA·08033737711309·THD PressKit is a practical and completely disp...
ACUMED
FDA UDI
Acumed LLC·10806378040245·2.0mm Clavicle Drill Guide / Depth Gage
OPENING TOOL
FDA UDI
Ortho Arch Company Inc·D90980014616·ECLIPSE SLB OPENING TOOL
EVOLVE EPS ORTHOLOC
FDA 510(k)
FDA Class 2
·Orthopedic
ZIRKONDENT
FDA 510(k)
FDA Class 2
·Dental
SUPERION INDIRECT DECOMPRESSION SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NQO·July 20, 2021
28MM DIA COCR MOD HEAD -6MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 8, 2014
ION¿
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·October 22, 2012
LEAD MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·August 10, 2010
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
FDA Enforcement
Class II
·Terminated·Cardinal Health Inc.·May 27, 2020
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 11, 2020