13 results · 20ms · 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.

PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY

FDA 510(k)
FDA Class 2 ·Radiology

Beekley Corporation

FDA registration
Beekley Corporation·9 products·🇺🇸 United States

TOMOSPOT

FDA Adverse Event
Injury ·BEEKLEY CORPORATION·Product code JAC·November 15, 2019

CD SPINAL FIXATION SYSTEM

FDA Adverse Event
Injury ·SOFAMOUR DANEK EUROPE·Product code KWP·May 19, 1999

EXPLORER GRADIENT

FDA 510(k)
FDA Class 2 ·Radiology

MODIFIED M-IV MAMMOGRAPHY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

BELLA BLANKETS

FDA Adverse Event
Malfunction ·BEEKLEY CORPORATION·Product code IZH·July 5, 2012

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 26, 2013

LIFEPAK 15 MONITOR/DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·March 10, 2011

SLR BIPOLAR ACETABULAR SHELL

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDI·March 28, 2008

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014