20 results · 23ms · Sources: EU EUDAMED, 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