14 results · 19ms · Sources: EU EUDAMED, 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