14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10
FDA 510(k)
FDA Class 2
·General Hospital
3D
FDA UDI
Rmo, Inc.·00885797100160·3D QUAD HELIX WILSON ASST OF 6
TOPCON
FDA UDI
VISIA IMAGING SRL·08034028770524·SOLOS Lite is an instrument intended for use by...
BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A
FDA 510(k)
FDA Class 2
·Cardiovascular
PROVIEW MEDICAL IMAGE DISPLAY MODULE
FDA 510(k)
FDA Class 2
·Radiology
EVOLUT FX DCS
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 24, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·March 13, 2013
SUMMIT POR TAPER SZ7 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code MRA·February 17, 2011
MILLENNIUM MPS
FDA Adverse Event
Malfunction
·GEMS ISRAEL, FUNCTIONAL IMAGING·Product code KPS·February 26, 2008
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018