91 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.

RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Atos Medical

FDA UDI
ATOS MEDICAL INC.·00817126020931·2010-068 Laryngectomy Pulmonary Kit with Standa...

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100080·Dilator Sleeve, Probe

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm

InTess C Cervical Cage System

FDA UDI
Kalitec Direct LLC·B07309K0100080·Caddie Lid, Implants and Instruments

NBS CONNECTING TUBE SET

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

COMPUMEDICS E-SERIES EEG SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2025

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·September 3, 2025

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER

AXSYM DIGOXIN III

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORP·Product code LZG·February 11, 2011

HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK

FDA Adverse Event
Malfunction ·HEARTWARE, INC.·Product code DSQ·September 16, 2025

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MRU·November 7, 2016

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR & EZ STEER FAMILIES OF CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·7 FR EZ STEER NAV DS BI-DIRECTIONAL W/ 8MM TIP ELECTRODE W/ DUAL THERMOCOUPLE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·EZ Steer Navigational 8mm (DS) ; Celsius FLTR Uni-Dir.

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS