22 results · 21ms · 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.

Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

N/A

FDA UDI
GEORGE TIEMANN & CO.·B58216042108·FORCEPS, RONGEUR, SURGICAL

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197059909·Piccolo Applicator, slender triangular Ø 0,8m...

SONARA; SONARA/TEK

FDA 510(k)
FDA Class 2 ·Radiology

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

Widex

FDA UDI
Widex A/S·05706069814361·Widex UNIQUE U-CIC TR (Clay brown ) 220, Left, ...

Widex

FDA UDI
Widex A/S·05706069814378·Widex UNIQUE U-CIC TR (Dark brown ) 220, Left, ...

Widex

FDA UDI
Widex A/S·05706069814354·Widex UNIQUE U-CIC TR (Light beige ) 220, Left,...

CAPSUREFIX MRI SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO·Product code NVN·June 10, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·October 10, 2014

TERUMO PERFUSION SYSTEM 8000

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code JOR·June 20, 2011

HUDSON CO2 SAMPLING CANNULA A, 7FT 2IN

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code CCK·April 26, 2016

V.A.C. GRANUFOAM DRESSING

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020

HUDSON CO2 SAMPLING CANNULA A, 7FT 7FT

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code CCK·April 22, 2016

SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS CANADA ULC·Product code HXX·October 10, 2025

Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 3, 2013

Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·January 21, 2015

Artis zeego, Model Number 10280959

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

Artis zeego, Model Number 10280959

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014