28 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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END TIDAL CO2 NASAL CANNULA
FDA 510(k)
FDA Class 2
·Anesthesiology
Unity Total Knee System
FDA UDI
CORIN LTD·05056139244001·UNITY KNEE™ PS-C INSERT - Size 5 x 18mm
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994241177·SCREW 3120518 4.0 X 18 SELF DRILL VAR
SMARTLOCK
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154156429·LOCKING SCREW, CROSS-PIN
ELMED
FDA UDI
ELMED INCORPORATED·00842180185197·WHITE TONSIL CLAMP
LEONE SPA
FDA UDI
LEONE SPA·08033707009559·CALIBRA 1ST MOLAR BANDS n.UR 18
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDELA SYMPHONY BREAST PUMP, MODEL 024
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
HF-RESECTION ELECTRODE, FOR TURIS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·February 9, 2023
BD POSIFLUSH¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 29, 2022
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code NPT·May 20, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO HEALTHCARE EQUIPMENT·Product code IOR·September 26, 2014
ONYX AVM
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code MFE·June 10, 2011
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·March 28, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·December 28, 2022
Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
FDA Recall
Open, Classified
·Diversatek Healthcare·Product code KNQ·March 18, 2026
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·April 27, 2023
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
FDA Enforcement
Class II
·Ongoing·Diversatek Healthcare·April 29, 2026