16 results
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36ms
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Sources: EU EUDAMED, US FDA
ISO-THERMEX
FDA 510(k)
FDA Class 2
·General Hospital
Bard® Urinary Drainage Bag With Anti-Reflux Dome
FDA UDI
C. R. Bard, Inc.·00801741040764·Bard® Urinary Drainage Bag With Anti-Reflux Dome
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190769·Femoral Impactor Pad small
OsteoMed
FDA UDI
OSTEOMED LLC·00845694025379·EnCompass .101 Guide Pin
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746031052·SUPPLIES - IMPRESSION TRAY UPPER SMALL PURPLE 2...
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746162862·SUPPLIES - IMPRESSION TRAY UPPER SMALL PURPLE 2...
Impression Tray
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746034978·SUPPLIES - IMPRESSION TRAY UPPER SMALL PURPLE 2...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197075725·Balfour Side-arm right
Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
MULTI-CELL ULTRAFILTRATION SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 19, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 4, 2012
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 18, 2020
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012