38 results · 23ms · Sources: EU EUDAMED, 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