11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GaleMed
FDA UDI
GaleMed Xiamen Co., Ltd.·24710810082911·Disposable Adjustable PEEP Valve 5-20cmH2O
RhythmView Workstation
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOMARK STERILE INDIA INK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ESCAPE NITINOL STONE RETRIEVAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FFL·November 19, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
SYNVISC ONE (HYLAN G-F 20) INJECTION
FDA Adverse Event
Injury
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·July 19, 2013
Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).
FDA Recall
Terminated
·Dow Corning Corp.·September 5, 2003
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023