12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023
Bernafon
FDA UDI
Bernafon AG·05711584115152·CO9 MNR T, 2.4G NFM MAC CAPTO 9 GPL
meijer
FDA UDI
MEIJER, INC.·00713733521598·Smart-Flex, Sterile Adhesive Bandages, assorted...
OXOID PYLORI TEST KIT, MODEL DR0130M
FDA 510(k)
FDA Class 1
·Microbiology
VUSION CS PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NTE·October 24, 2008
CRYSTALENS
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code NAA·August 11, 2011
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
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
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