12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
JAWS Staple System
FDA UDI
Paragon 28, Inc.·00889795049827·JAWS Trial Sizer 15mm and 18mm
VITALSAT SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
FDA 510(k)
FDA Class 2
·General Hospital
I-STAT CG8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·January 5, 2022
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·February 1, 2022
GDC COIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code HCG·October 22, 2008
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 5, 2011
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
FDA Enforcement
Class I
·Ongoing·Abbott Vascular·May 25, 2022
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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.·August 5, 2015