11 results
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18ms
·
Sources: EU EUDAMED, US FDA
CHLORIDE/CARBON DIOXIDE RATE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317361349·
A-FIT®
FDA UDI
Gc Orthodontics America Inc.·E53581170100001·A-FIT® 2. MOLAR UPR RGT SZ 01
X-Guide® Surgical Navigation System
FDA 510(k)
FDA Class 2
·Dental
BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 23, 2007
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 31, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2014
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024