41 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IDS Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112755·BARRON VACUUM PUNCH 7.5MM
Conventional Lead Apron .5mm Xtra Xtra Large 26 X 42
FDA UDI
Flow X Ray Corporation·00843696123895·Conventional Lead Apron .5mm XXL 26 X 42, Hunte...
Tissue Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668111192·STEEL BASE FOR BARRON AAC
Fluid Retention Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668112854·VIDAURRI FLUID RETENTION WELL 8.7MM
VESSEL GUARDIAN
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Shear Wave Quantificational Ultrasound Diagnostic System
FDA 510(k)
FDA Class 2
·Radiology
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·October 6, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
THERASPHERE Y-90 (10.5 GBQ) CN CLINICAL
FDA Adverse Event
Injury
·BIOCOMPATIBLES UK LIMITED·Product code NAW·January 24, 2022
RESTOR APODIZED IOL
FDA Adverse Event
Injury
·ALCON·Product code MFK·October 14, 2008
CARELINK PROGRAM W/TELEMETRY C
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·August 11, 2011
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 2, 2013
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Enforcement
Class I
·Terminated·B Braun Medical Inc·May 11, 2016
GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·August 19, 2021
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·October 6, 2021
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 12, 2021
FREEZOR XTRA CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code LPB·November 2, 2021
ABSORBABLE GELATIN
FDA Adverse Event
Injury
·PFIZER, INC.·Product code LMF·June 25, 2021
ENDOLOOP LIGATURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GEA·October 6, 2021