11 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.

ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES

FDA 510(k)
FDA Class 2 ·Ophthalmic

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496042242·ALISEA 70, SIZE ML, MOKA, GRADUATED COMPRESSION...

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809871128·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...

POLESTAR N-10

FDA 510(k)
FDA Class 2 ·Radiology

FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 9, 2013

ZIMMER UNIVERSAL LOCKING SYSTEM SCREW

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code HWC·February 15, 2011

CONTAK RENEWAL 4

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013