406 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PAIRED HYDROGEL ELECTRODE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306815539·Ribbon Retractor, Malleable, Width: 38 mm, Leng...
Posted Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90911013811·.018 POSTED SS RIGHT FORM WIRES 38MM (10)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450292464·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450293027·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450292259·
3.8 x 230 mm Surgibit Drill
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055103·The saleable unit (device count) is 1, there ar...
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROFILE II ER
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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
TRIATHLON PS X3 TIBIAL INSERT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2013
COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·September 23, 2014
COULTER® LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·June 1, 2011
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 17, 2025
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 19, 2025
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code NJR·April 17, 2026
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 14, 2026
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026