19 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
RAPID FIRE
FDA Adverse Event
Injury
·CONMED ENDOSCOPIC TECHNOLOGIES·Product code FHN·September 9, 2006
RAPID FIRE
FDA Adverse Event
Injury
·CONMED ENDOSCOPIC TECHNOLOGIES·Product code FHN·September 9, 2006
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROFEMUR TL CLASSIC HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
BARD
FDA Adverse Event
Injury
·BAND ENDOSCOPIC TECHNOLOGIES C.B.BARD. INC.·Product code NKQ·May 25, 2004
1223688-2000-00027
FDA Adverse Event
Injury
·Product code FDI·September 27, 2000
1223688-1999-00039
FDA Adverse Event
Injury
·December 28, 1999
1223688-1999-00038
FDA Adverse Event
Injury
·December 27, 1999
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
RAPID FIRE
FDA Adverse Event
Malfunction
·CONMED ENDOSCOPIC TECHNOLOGIES, INC.·Product code FHN·March 10, 2007
RAPID FIRE
FDA Adverse Event
Malfunction
·CONMED ENDOSCOPIC TECHNOLOGIES, INC.·Product code FHN·March 10, 2007
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
CIDEX REGULAR
FDA Adverse Event
Injury
·ADVANCED STERILIZATION PRODUCTS·Product code LRJ·August 25, 2011
LPS DISTAL FEM COMP XSM LT
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 12, 2013
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·May 18, 2016
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024