19 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VASCUCLEAR PRECISION BIPOLAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JOSTRA SUCKERS, MODEL JS
FDA 510(k)
FDA Class 2
·Cardiovascular
KYPHON HV-R BONE CEMENT
FDA Adverse Event
Injury
·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 25, 2017
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·April 7, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 19, 2020
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 4, 2019
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Injury
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 17, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·December 17, 2018
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 7, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 12, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 9, 2020
ASR XL TAP SLV ADAP 12/14+2
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·May 20, 2013
STERLING BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·June 13, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·August 13, 2008
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023