15 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CLIRPATH EXCIMER LASER CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Leksell Vantage Stereotactic System
FDA UDI
Elekta Solutions AB·07340201501863·ARC SUPPORT LEFT
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319735152·Hand Chisel 5-1/8" (131mm), curved edge, 7.2mm ...
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935103370·
GYRUS ENT SOMNOPLASTY GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALIGN TO URETHRAL SUPPORT SYSTEM-HALO
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·April 3, 2013
RESERVOIR 1.8 ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·March 25, 2011
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·May 7, 2008
IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code ONU·June 6, 2025
TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility.
FDA Recall
Terminated
·Product code FIN·March 26, 2012
TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility.
FDA Enforcement
Class II
·Terminated·Tango3 LLC·August 15, 2012
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024