14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169601222·SPACER 2110255 OLIF25 20MM 0 DEG 10X55
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584610·Apex Tibial Nail Ø 11.0 x 255mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100550·Caddie, Misc Screws
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·November 12, 2019
ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CAVITY VARNISH
FDA 510(k)
FDA Class 2
·Dental
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
UNKNOWN MICROCATHETER
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017
UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·May 13, 2013
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 11, 2014
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 20, 2011
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025