18 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT
FDA 510(k)
FDA Class 2
·Anesthesiology
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
FDA 510(k)
FDA Class 2
·Anesthesiology
ZelanteDVT Thrombectomy Set
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 3, 2008
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·August 12, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 29, 2013
Hitachi Oasis MRI System - C-Spine Coil
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code LNH·January 6, 2017
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code JAK·June 30, 2015
Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code JAK·November 5, 2008
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
FDA Recall
Open, Classified
·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
FDA Recall
Open, Classified
·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
FDA Recall
Open, Classified
·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
FDA Recall
Open, Classified
·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021
OASIS MRI System
FDA Recall
Terminated
·Hitachi Healthcare Americas Corporation·Product code LNH·July 29, 2021
ECHELON Oval MRI System
FDA Recall
Terminated
·Hitachi Healthcare Americas Corporation·Product code LNH·July 29, 2021
ECHELON MRI System
FDA Recall
Terminated
·Hitachi Healthcare Americas Corporation·Product code LNH·July 29, 2021
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
FDA Recall
Open, Classified
·Hitachi Healthcare Americas Corporation·Product code IYN·June 30, 2021