54 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
Stansion Matrix®
FDA UDI
INNO Holdings, Inc.·M711B0810070·
Stansion Matrix®
FDA UDI
INNO Holdings, Inc.·M711C0810070·
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180504895·Battalion, LLIF Cup Curette, Up Angled 40deg, S...
Baby Gorilla/Gorilla Plating System
FDA UDI
Paragon 28, Inc.·00889795034519·Gorilla, Posterolateral, Fibular, 07-Hole, Beta
ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL
FDA 510(k)
FDA Class 1
·General Hospital
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
FDA 510(k)
FDA Class 2
·Orthopedic
WAVEWRITER ALPHA PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 5, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
DUO FLUID CART
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·December 21, 2017
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·August 31, 2018
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 24, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 9, 2014
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·April 14, 2011
ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·June 25, 2020
EVAC STATION
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·September 5, 2017
ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·January 11, 2018
EVAC STATION
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·January 16, 2018
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·June 7, 2018
ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·August 3, 2017