13 results
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19ms
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Sources: EU EUDAMED, US FDA
CTS SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150713·K-WIRE - SINGLE TROCAR 1.0mm DIA x 100mm
Life Instruments
FDA UDI
Life Instrument Corporation·M930794100400·Cone Suction Tube 4mmx160mm
INTRAOSSEOUS FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
FDA 510(k)
FDA Class 1
·General Hospital
THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 26, 2024
NA
FDA UDI
Zimmer, Inc.·00889024206342·
OCTRODE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 30, 2013
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·December 8, 2010
CONCORDE BONE FUNNEL 8MM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code LXH·July 17, 2014
ADVANTA V12 COVERED STENT
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code NIO·February 26, 2021
HEMOCHRON SIGNATURE ELITE
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS·Product code JPA·May 25, 2016
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021