15 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Portex
FDA UDI
ICU MEDICAL, INC.·15019517077612·
Tizian Blank 5.0
FDA UDI
Pritidenta GmbH·04251366906055·
priti®multidisc ZrO2
FDA UDI
Pritidenta GmbH·04251366905010·
GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
FDA 510(k)
FDA Class 2
·Physical Medicine
Altus Spine HA Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
BD NEEDLE 22GA 1-1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·June 14, 2024
TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON, SARL·Product code FTL·November 4, 2008
8MM MCS TIP COVER ACCESSORY
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·August 23, 2011
VANGUARD ANTERIOR STABLIZED BEARING 12X63
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 11, 2013
BD MICROLANCE NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·November 7, 2024
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
FDA Enforcement
Class I
·Ongoing·Ventec Life Systems, Inc.·March 6, 2024
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
ARROW Endurance Extended Dwell Peripheral Catheter System
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021