20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALMA LASERS FAMILY OF PIXEL RF TIPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380077432·1.25mm Non-Threaded Guide Wire 150mm
CHS
FDA UDI
Smith & Nephew, Inc.·03596010062239·AMBI COMPRESSION HIP SCREW PLATE 10SL 220MM 130D
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564031907·Knee Bump Pack
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045315·PrimaLIF LLIF PEEK Implant, 11mm X 18mm X 50mm,...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780377238·Integra® Jarit® Olsen-Hegar Needle Holder, 5-3/...
NIOX
FDA UDI
Circassia AB·07350047030366·This is a rechargeable Li-Ion replacement batte...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172974032·UniTip High Resolution Catheter 12F
COULTER CELLPREP
FDA 510(k)
FDA Class 1
·Hematology
PICC WAND PEELABLE SAFETY INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197030601·Nerve Dissecting Scissors
curved...
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 29, 2014
CONTOUR
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019
BD VACUTAINER® PLUS CITRATE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 3, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
NC QUANTUM APEX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·June 13, 2011
EGIA 45 ARTICULATING MED/THICK SULU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·December 9, 2015
XP-CR Tibial Tray - Interlok 73mm Item # 195274
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019