14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXTERNAL FIXATOR ST.A R 90 F4
FDA 510(k)
FDA Class 2
·Orthopedic
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·June 9, 2017
SHARGHP A.V. FISTULA NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ESCALADE ACETABULAR CUP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TEMPORARY PACING WIRE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code LDF·May 15, 2013
SHILEY DISPOSABLE CANNULA LOW PRESSURE
FDA Adverse Event
Injury
·COVIDIEN/ FORMERLY TYCO HEALTHCARE·Product code JOH·May 26, 2011
STRATUS CS STAT FLUOROMETRIC ANALYZER
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 8, 2008
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 2, 2015
NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code BSP·September 17, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 3, 2015
PRECISIONGLIDE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 17, 2026
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025