12 results · 18ms · 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.

HENKE JECT PRESSURE SYRINGE

FDA 510(k)
FDA Class 2 ·Dental

LEONE SPA

FDA UDI
LEONE SPA·08033707029021·WEB 1ST MOLAR BANDS n.UL 24

BREATHID HP SYSTEM

FDA 510(k)
FDA Class 1 ·Microbiology

CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN

FDA 510(k)
FDA Class 2 ·Cardiovascular

WALKMED® 150 ML RESERVOIR BAG

FDA Adverse Event
Malfunction ·WALKMED TECHNOLOGIES, LLC·Product code FRN·September 5, 2025

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 23, 2014

M2A-MAGNUM 42-50 TPR INSRT STD

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·November 13, 2012

DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010

PFNA BLADE PERF L95 SST

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·June 20, 2018

Pressure Monitoring Set, C-PMS, G02838

FDA Enforcement
Class II ·Terminated·Cook Inc.·June 10, 2020

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

FDA Enforcement
Class II ·Completed·Cook Incorporated·July 20, 2022

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018