51 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REJUVENATE MODULAR HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 44mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665025248·
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609164·SKYTRON 4" DELUXE
Phasor Drill
FDA UDI
BIOTEX, INC.·M710PH530700·2 Flute Drill Bit.
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
FDA 510(k)
FDA Class 1
·General Hospital
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 22, 2020
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
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 26, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·April 14, 2011
PRESEP - CENTRAL VENOUS OXIMETRY CATHETER KIT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DQA·July 18, 2008
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
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·March 19, 2018
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·June 11, 2021