179 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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DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
Premier K-FILES
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6919053240·FILES PKG 6 25MM 50
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809842562·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE SMALL ...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690185420·Revision Knee Spiral Reamer- Hudson Short Flute...
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981174156·L Con, Side-Loading, L, 16mm, 240mm
BIOMET EXTERNAL WRIST PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ST AIA-PACK CA 19-9
FDA 510(k)
FDA Class 2
·Immunology
SELUTE PICOTIP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 11, 2013
INSYNC SENTRY
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·April 13, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP·Product code CBK·May 28, 2008
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·October 30, 2013