26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS
FDA 510(k)
FDA Class 2
·General Hospital
AXS
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327358476·BONE SCREW, AXS, SELF-DRILLING
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540365041·Bone Screws, Cross-Pin, self-drilling
EVEREST® Spinal System
FDA UDI
VB Spine LLC·10888857531567·T-Handle Inserter
BD SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 16, 2019
ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
FDA 510(k)
FDA Class 2
·Hematology
ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·February 20, 2013
CRE¿ WIREGUIDED
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code KNQ·September 7, 2012
CRE? WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 18, 2013
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·January 7, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014
AED PRO
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 25, 2011
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·March 13, 2013
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·August 10, 2012
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
CRE? WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 6, 2013