11 results · 23ms · 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.

Uroview FD II

FDA 510(k)
FDA Class 2 ·Radiology

STABILIZ FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CELESTEION, PCA-9000A/2

FDA 510(k)
FDA Class 2 ·Radiology

LOCKING SCREW, FULLY THREADED 5X55 MM

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 30, 2010

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 15, 2014

IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code MTF·June 20, 2013

HS III PROXIMAL SEAL

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·May 5, 2011

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 4, 2023

STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·April 1, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Pump Model 1700 pump, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. REF 21-1801-81, 21-1803-81, 21-1805-49/51/81, 21-1806-51/81, 21-1807-49

FDA Recall
Terminated ·Smiths Medical MD, Inc.·Product code LZG·March 10, 2008