16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EQUINOX Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017941·K-Wire, Double Ended, Trocar Point, Diameter Si...
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101094·HELVESTON "BIG BARBIE" RETRACTOR 9MM
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017958·K-Wire, Double Ended, Trocar Point, Diameter 0....
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306822780·Poole Aspiration Tube - 30fr with valve
LinkBio Instrument
FDA UDI
Link Bio Corp·00810022402320·Guide Rod, Tibial Cone, D 12/180 L
BENACEL
FDA 510(k)
FDA Unclassified
·Unknown
FM20
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SilverGlide
FDA UDI
STRYKER CORPORATION·04546540695925·ProSeries Non-stick Bipolar Electrosurgical For...
SILVERGLIDE
FDA UDI
STRYKER CORPORATION·04546540532268·Non-Stick Bipolar Electrosurgical Precision For...
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·October 3, 2008
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 26, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025
Merge Hemo, Software packages 10.2, 10.3, and 10.4
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·September 8, 2021