38 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481121692·LOCATOR F-Tx Abutment for Regular Platform Tiss...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481114083·LOCATOR R-Tx Abutment for Regular Platform Tiss...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031462·1.6mm Modified LeFort Plate, Left, 5mm
APEX 90
FDA 510(k)
FDA Class 2
·Dental
RAUMEDIC- ICP-MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857560031·Angled Curette Size 3 mm
Vu cPOD™
FDA UDI
Seaspine Orthopedics Corporation·10889981039455·Implant Tapered 10x12x6mm (Non-Strut)
DRACO
FDA UDI
HNM TOTAL RECON LLC·00841742122090·DRACO MetaFuse OpenWedge Plate, Ti - #6, R
Integra-Ti
FDA UDI
BICON, LLC·00813110027429·3.0 x 6.0mm Integra-Ti Implant - 2.0mm Well
Mayo-Hegar Needle Holder
FDA UDI
ELMED INSTRUMENTS(PVT)LTD.·G165SU130206160·Intended Use: Mayo Hegar Needle Holder is commo...
Mayo-Hegar Needle Holder
FDA UDI
ELMED INSTRUMENTS(PVT)LTD.·G165SU130206130·Intended Use: Mayo Hegar Needle Holder is commo...
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
WHEELCHAIR COMPONENTS
FDA Adverse Event
Malfunction
·UNKNOWN·Product code INM·May 24, 2013
6F ANGIO-SEAL EVOLUTION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·June 10, 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