247 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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CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033058·Baltic Denture System BDLoad Lw6 PLSEbil2DFl D2...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319735060·Skeele Chalazion Curette, round cup 2 mm, serra...
INSTANT-VIEW Cocaine (150) Urine Dip-Strip Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000436·INSTANT-VIEW Cocaine (150) Urine Dip-Strip Test
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330080·Rocker, Hinged, Locking
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LASER 3 SPSC300
FDA 510(k)
FDA Class 2
·Physical Medicine
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013
R SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 25, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·April 23, 2008
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 18, 2025
NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026