16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
FDA 510(k)
FDA Class 2
·General Hospital
TruLink
FDA UDI
OSI OPTOELECTRONICS, INC.·00859998006491·SpO2 Foam Sensor Single-patient Use Adult
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028291·PESSARY, GEHRUNG #1, 55mm
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522102332·SENSOR,SPO2,FOAM,ADULT,SPU,24/BX,ROHS
FEMVUE CORNUAL BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
QUANTA LITE SP100 ELISA
FDA 510(k)
FDA Class 2
·Immunology
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 17, 2024
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 6, 2011
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·June 6, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
AXIOS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 27, 2024