20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KOALA CLAMP, KOALA CLAMP AND CUTTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780736·LEVAMED ACTIVE ANKLE SUP SLVR L I
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040047569·Curette Gracey DE 3/4 Long
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040009345·Zirlux 16+ O1 coloring liquid
Solidity Vertebral Body Replacement
FDA UDI
Ulrich Medical Usa, Inc.·00814386022286·Center piece, yellow, Ø 13mm, height 16-21.5mm,...
DARDIK CAROTID SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-SPACE ABSORBABLE SEEDING SPACERS
FDA 510(k)
FDA Class 2
·Radiology
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 6, 2025
XPS® BUR GUARD - VISAO®
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ERL·April 22, 2016
PROFEMUR(R) Z STEM PLASMA SPRAYED
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·March 19, 2013
EBICE MODEL 10D
FDA Adverse Event
Injury
·EBI, LLC·Product code ILO·March 9, 2011
INTRATHECAL
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·March 10, 2008
XPS® BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·March 13, 2017
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·January 17, 2025
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·January 17, 2025
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·January 3, 2025
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·January 3, 2025
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018