16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear
FDA 510(k)
FDA Class 2
·Ophthalmic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517638076·CoRoent Ant TLIF PEEK, 15x13x30mm 15°
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699571·GENUMEDI PSS BLUE, SIZE V
Sklar®
FDA UDI
SKLAR CORPORATION·10649111048593·SKLHN METZ LAHEY SCIS STR 5.75
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100301·INFANT WIRE SPECULUM 3MM/5MM BLADES
PENUMBRA EMBOLIZATION COIL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
ESON 2 NASAL MASK
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 26, 2024
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 15, 2024
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 8, 2013
STRAUMANN BONE CERAMIC
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code LYC·June 30, 2011
WALLSTENT RX BILIARY ENDOPROSTHESIS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code FGE·September 5, 2008
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·March 18, 2019
Scanlan Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled micro fine blades, 8'', 20 cm. Catalog Number 7007-449-8.
FDA Recall
Terminated
·Product code DXY·July 27, 2005
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023