18 results · 29ms · 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.

StatStrip Xpress Glucose Hospital Meter System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ZenFlex

FDA UDI
Kerr Corporation·00195062030024·Rotary Files

IN-OVATION® R

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189552821·IN-OVATION® R EURO 022 UL/5-5 CS-BC HK

IN-OVATION® R

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189552811·IN-OVATION® R EURO 022 UL/5-5 CS HK

HEMOSIL LA POSITIVE CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

U&U STERILE HYPODERMIC NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL 46

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 6, 2020

COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·October 21, 2024

AL-III W/FOOT CONTROL

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·October 17, 2014

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 21, 2013

TERUMO PERFUSION SYSTEM 8000

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code JOR·July 11, 2011

MODIFIED NOVY CORNUAL CANNULATION SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MOV·March 14, 2024

COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·March 29, 2024

MODIFIED NOVY CORNUAL CANNULATION SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MOV·January 10, 2024

MODIFIED NOVY CORNUAL CANNULATION SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MOV·November 22, 2024

COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·March 28, 2024

COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·December 28, 2023

Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

FDA Enforcement
Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023