27 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex DualCompression Hindfoot Fusion Nail Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
BD Difco™ QC Antigen Shigella Group C
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902210313·Vial Qc Antigen Shigella Grp C 1Ml
IQ FLEX M
FDA Adverse Event
Malfunction
·FIRST SOURCE INC.·Product code IZL·May 29, 2024
EN SNARE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code MMX·September 8, 2011
WAVELIGHT FS200 PATIENT INTERFACE 1505
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EBI XFIX RAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·November 3, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·August 23, 2011
135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 4 HOLES
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code KTT·July 11, 2013
UNSPECIFIED BD PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 18, 2020
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
FDA Enforcement
Class III
·Terminated·MICROVENTION INC.·June 16, 2021
SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022