16 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACTIVE® Free Testosterone RIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169599178·TRIAL 2191350 O25 IB 27MM 6 DEG 12X50
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583032160·ET40 MNR, 2.4G NFM PB GR ENCHANT 40
Sklar®
FDA UDI
SKLAR CORPORATION·10649111386466·TISSUE FCP FLUTED HDL 1X2 4.5"
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780418764·Integra® Miltex® Lempert Endaural Curette, 8-1/...
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110911·SQUEEZE HANDLE CLEANING TUBE
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78819135000201·EXMRC MBT 018/LL5 - 17T 2A
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78819135000101·EXMRC ROTH 018/LL5 - 22T - 1A 4D
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017053·Wide Jaw Punch large 3.5mm 30 degree right
RADSCAN EQUIPMENT SLICKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ESTECH HAWKEYE INTRODUCER SYSTEMS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 9, 2008
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·July 27, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013
CELL-DYN 3500 CS ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·September 20, 2010
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017