13 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.

EXTRACTORRX

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

artegral

FDA UDI
Merz Dental GmbH·D7091970052·anteriors; shade A2; mould UBL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS

Stellaris Elite vision enhancement system

FDA 510(k)
FDA Class 2 ·Ophthalmic

MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION

FDA 510(k)
FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER).

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER

STELLARIS ELITE VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

25 GA POSTERIOR WIDE-FIELD ELITE PACK

FDA Adverse Event
Malfunction ·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code BTI·February 20, 2013

TERUMO CDI 540 CALIBRATOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·January 14, 2011

EMERGE?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 31, 2014

STELLARIS POWER SUPPLY II

FDA Adverse Event
Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023