68 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Medline Orbis Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BARD ER URETERAL STENT WITH SUTURE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CADD SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·July 28, 2023
CRYSTALENS
FDA Adverse Event
Malfunction
·BAUSCH & LOMB SURGICAL·Product code HQL·October 8, 2008
EGIA ULTRA UNIVERSAL STAPLER
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·August 5, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 2, 2013
SELECTSECURE MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2024
CAPSUREFIX NOVUS LEAD MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 10, 2024
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·March 6, 2024
MICRA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code PNJ·May 3, 2024
O-ARM IMAGING SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·August 22, 2024
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·August 23, 2024
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·September 3, 2024
GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·September 8, 2024
ACHIEVE MAPPING CATHETER - 20 MM
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DRF·September 3, 2024
Y-90 THERASPHERE
FDA Adverse Event
Death
·BIOCOMPATIBLES UK LIMITED·Product code NAW·September 4, 2024