16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Intense Pulsed Light Treatment System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158210578·FORCEPS DEBAKEY ATRAUMATIC TISSUE 2MM TIP STRAI...
Lumbar IBFD
FDA UDI
KEOS·B084KPS12308160·
Lumbar IBFD
FDA UDI
KEOS·B084KPS22308160·
INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)
FDA 510(k)
FDA Class 2
·Neurology
MSD CABLE REDUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMP TM 3.7MM MTX,10MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·December 4, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2024
22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 26, 2017
SOLUSET 150 X 60 BURETTE SET, LATEX FREE
FDA Adverse Event
Malfunction
·HOSPIRA DE COSTA RICA LTD.·Product code FPK·November 6, 2008
JUVEDERM (VOLUME/CONCENTRATION UNK)
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·August 23, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 30, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 23, 2025
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 4, 2024