35 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPACELABS HEALTHCARE CARDIOEXPRESS
FDA 510(k)
FDA Class 2
·Cardiovascular
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925013063·SCHUKNECHT STRAIGHT PICK
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031479·1.6mm Modified LeFort Plate, Right, 5mm
Trivicta
FDA UDI
Ortho Development Corporation·00822409123599·Collar STD Size 7
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857560048·Angled Curette Size 4 mm
Vu cPOD™
FDA UDI
Seaspine Orthopedics Corporation·10889981039462·Implant Tapered 10x12x7mm (Non-Strut)
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
FDA 510(k)
FDA Class 2
·Ophthalmic
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
FDA 510(k)
FDA Class 1
·General Hospital
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 16, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP·Product code CBK·May 22, 2013
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·May 9, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 22, 2008
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026
HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 10, 2019
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 10, 2017
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·August 3, 2022
INSPIRE 6 HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·February 25, 2022