15 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ANGIOJET ULTRA POWER PULSE KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

EVONOS

FDA UDI
Gyrus ACMI, LLC·00821925013841·JORDAN ANGULAR KNIFE 3 MM BLADE LENGTH 45 DEGRE...

ArgenZ HT+ 98x20 ML C4B

FDA UDI
ARGEN CORPORATION, THE·D818130381·Dental porcelain/ceramic restoration kit

EMERGE?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026

CELL-DYN EMERALD 22 SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

OMNIPOD INSULIN MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·September 20, 2020

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 24, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 30, 2014

PACEART SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code DPS·June 16, 2011

VASO VIEW HEMOPRO

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019

MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

FDA Enforcement
Class II ·Terminated·Ecolab Inc·February 19, 2014

DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024