44 results · 21ms · Sources: EU EUDAMED, US FDA

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Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113967·HYDRO-DISSECT CANNULA 25GA ANGLED 7MM

Advanix Biliary Stent with NaviFlex RX Delivery System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ADVANIX BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 8, 2025

ADVANIX BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 5, 2024

ADVANIX? BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 8, 2025

ADVANIX BILIARY

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 30, 2024

ADVANIX BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 21, 2025

ADVANIX BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·February 4, 2025

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003165·270 micron Holmium Laser Fiber Cable, Reusable,...

Oph. Cystotomes

FDA UDI
KATENA PRODUCTS, INC.·00841668113684·CYSTOTOME FORMED 27GA

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112977·CORNEAL TREPHINE BLADE9.0MM

ELECSYS PTH CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

FDA Enforcement
Class II ·Terminated·Anodyne Surgical·June 23, 2021

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020

PULMONETIC

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC·Product code CBK·October 10, 2008

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

COULTER AC*T DIFF 2 ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·July 2, 2013

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

FDA Recall
Terminated ·Anodyne Surgical·Product code HMX·April 21, 2021

CHECK-IT

FDA Adverse Event
Malfunction ·PFIZER, INC.·Product code QJR·May 23, 2023