26 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AHI System
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813834·GENUMEDI PRO SILVER SIZE III
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205004130·Luna Opal MB Mini .022 Kit 5x5 U & L Hooks 3
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242579·Mini Transverse Coupler Size (L)
Cliq Aspirator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BOSTON KERATOPROSTHESIS OR BOSTON KPRO
FDA 510(k)
FDA Class 2
·Ophthalmic
CAPTURE-R READY INDICATOR CELLS
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·August 13, 2008
NEEDLE,25GX1.5",REG,BEVEL
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES LP·Product code FMI·December 13, 2024
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·November 5, 2008
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·August 24, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 11, 2013
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·October 25, 2023
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 19, 2013
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020