12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ActiPatch
FDA 510(k)
FDA Class 2
·Physical Medicine
Edge™ Diamond FP023-5C Football Pointed
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003292·Diamond dental bur, reusable
DYNESYS TOP-LOADING SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
A-DEC 200 DENTAL SYSTEM
FDA 510(k)
FDA Class 1
·Dental
TPRLOC COCR CMTD STM T1 12.5MM
FDA Adverse Event
Death
·BIOMET UK LTD.·Product code JDI·March 23, 2026
CMK MOD 12/14 SZ202 L130
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LZO·November 24, 2025
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWY·July 20, 2023
CMK MOD 12/14 SZ202 L130
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·January 8, 2026
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018