13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Anterion
FDA 510(k)
FDA Class 2
·Ophthalmic
NA
FDA UDI
Synthes GmbH·10886982151551·2.4MM CANNULATED SCREW LONG THREAD 17MM
Diamond Orthopedic, LLC
FDA UDI
DIAMOND ORTHOPEDIC, LLC·B551DMD2118170·2.4mm, Cannulated Screw, Long Thd., 17mm
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2118170·2.4mm Cannulated Screw, Long Thread, 17mm
BRIDGE FX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PALINDROME RT CHRONIC CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
FDA 510(k)
FDA Class 2
·General Hospital
10MM INZII RETRIEVAL SYSTEM 10/BOX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·October 29, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·August 10, 2011
LINOX SMART SD 65/16
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·July 8, 2013
Deltec Cozmo Insulin Pump, model 21-1800. This is similar to the currently distributed Deltec Cozmo Insulin Pump Model 1700, 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. Reorder Numbers: 21-1801-81 21-1803-81 21-1804-81 21-1805-49/51/81 21-1806-49/51/81 21-1807-49/51/81 21-1815-01/50 21-1816-01/50 21-1817-01/50
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code LZG·February 22, 2008
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025