9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AXON IR Heat Lamp
FDA 510(k)
FDA Class 2
·Physical Medicine
REPROCESSED RESTEP COMPRESSION SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
VIS-U-ALL II HEAT-SEAL POUCH AND TUBING
FDA 510(k)
FDA Class 2
·General Hospital
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 14, 2013
DUROM US ACETABULAR COMPONENT 54/48 N
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·July 8, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·BIOENTERICS CORP·Product code LTI·September 18, 2008
INVISION¿ TOTAL ANKLE SYSTEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 18, 2022
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018