25 results · 38ms · Sources: EU EUDAMED, US FDA

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PERIOPATCH

FDA 510(k)
FDA Unclassified ·Unknown

NexxZr™ / W-98-30-UT-A400-ML

FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271138729·

AGXO

FDA UDI
Oticon A/S·05707131163776·K130, MINIRITE CBE AGXO

Sklar®

FDA UDI
SKLAR CORPORATION·10649111189715·CLEAR PLASTIC TRAY MD 4" DEEP

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172971185·

AUTOSTAT II ENA-6 PROFILE ELISA

FDA 510(k)
FDA Class 2 ·Immunology

KONICA DIRECT DIGITIZER REGIUS MODEL 350

FDA 510(k)
FDA Class 2 ·Radiology

9611993-2025-103054

FDA Adverse Event
Injury ·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·July 11, 2025

V200 / ESPRIT

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 16, 2021

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 28, 2021

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·May 19, 2021

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code CBK·May 20, 2021

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·June 7, 2021

V200 VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code CBK·December 9, 2020

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·June 21, 2021

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 9, 2013

CHOICE GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·September 19, 2014

M2A MAGNUM PF CUP 52MM X 46MM ID

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 25, 2011

Infant Warmer System (IWS)

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·January 18, 2017

Infant Warmer System (IWS)

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·June 21, 2017