11 results · 18ms · Sources: EU EUDAMED, US FDA

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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