13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GEM FLOW COUPLER DEVICE AND SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Hook
FDA UDI
KATENA PRODUCTS, INC.·00841668103340·BECHERT LENS PUSHER ANGLED
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL
FDA 510(k)
FDA Class 2
·Orthopedic
BD ULTRASAFE PLUS¿ X100L PNG CLEAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code FMI·November 7, 2024
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Malfunction
·COOK INC·Product code MIH·November 26, 2019
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 29, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 17, 2011
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·August 21, 2008
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·February 5, 2014
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
FDA Enforcement
Class II
·Terminated·Neurotherm, Inc.·April 20, 2016
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
FDA Recall
Terminated
·Zimmer Dental Inc·Product code DZE·January 6, 2014
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023