12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Blue Nitrile Examination Gloves Powder Free
FDA 510(k)
FDA Class 1
·General Hospital
Bernafon
FDA UDI
Bernafon AG·05711584114612·CO5 MNR, 2.4G NFM SABE DEMO CAPTO 5 GPL
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
PULSE GEN MODEL 102R
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·October 24, 2008
PULSE GEN MODEL 101
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·August 11, 2011
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 9, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code KMW·April 25, 2022
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code KMW·July 7, 2022
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023