10 results
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17ms
·
Sources: EU EUDAMED, US FDA
IRMA BLOOD ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981270·anteriors; shade C2; mould CL2
Symmetry
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482087459·Symmetry® Forceps, Claw, Ratcheting Handle w/Ro...
GAMBRO MULTIPURPOSE SYSTEM MPS-10
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable SpO2 Sensors, Reusable SpO2 Sensors
FDA 510(k)
FDA Class 2
·Cardiovascular
180MM 2/3 RING
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KTT·October 19, 2017
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code OUT·February 27, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 1, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·August 5, 2014
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·February 22, 2017