9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHANNEL BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
artegral
FDA UDI
Merz Dental GmbH·D7091970379·anteriors; shade D2; mould CS
Disposable Standard Clamp
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TROCAR SLEEVE SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 20, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 31, 2014
CBCII BLOOD CONSERVATION KIT W/1/8 INCH ROUND PVC
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS PUERTO RICO·Product code CAC·January 18, 2011
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 21, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022