22 results · 28ms · 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.

Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating

FDA 510(k)
FDA Class 1 ·General Hospital

Forearm Plate, Curved

FDA UDI
I.T.S. GmbH·09120047307212·Forearm Plate, Curved, 11-Hole

IMAGEN Parainfluenza Virus Types 1, 2 and 3

FDA UDI
OXOID LIMITED·05032384502974·

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383535700·Gutta Percha Points is used to root canal filin...

B-P TOTAL HIP SYSTEM

FDA UDI
ENDOTEC, INC.·00814193024183·B-P MODULAR EXTENSION W/ULTRACOAT - 11 MM X 100 MM

VARIOUS DENTAL IMPLANTS

FDA 510(k)
FDA Class 2 ·Dental

RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM

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

PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT

FDA Adverse Event
Injury ·COVIDIEN·Product code NIO·March 7, 2017

PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM

FDA Adverse Event
Injury ·COVIDIEN·Product code NIO·March 7, 2017

CONSULTA CRT-D

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014

SECURA DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2013

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2011

V.A.C. GRANUFOAM DRESSING

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

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·May 3, 2016

KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

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

LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·December 28, 2016

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