13 results · 21ms · Sources: EU EUDAMED, US FDA

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SOEHENDRA STENT RETRIEVER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Brigade

FDA UDI
Nuvasive, Inc.·00887517962324·Brigade Lateral Trial, 8x34x28mm 30°

EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Stylet

FDA UDI
Bard Access Systems, Inc.·00801741013744·EQUISTREAM HEMODIALYSIS CATH w/STYLET, ST, AIRG...

E1 RINGLOC POLY LINER MAX-ROM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 8, 2018

BIOLOX DELTA CERAMIC OPTION HEAD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 8, 2018

EcoFit® Hip System

FDA 510(k)
FDA Class 2 ·Orthopedic

XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

FDA Adverse Event
Malfunction ·ZYNO MEDICAL, LLC·Product code FRN·February 26, 2021

NI

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code KWP·November 15, 2010

MALLINCKRODT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TYCOHEA, AVENIDA HENEQUEN·Product code BTR·January 2, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 30, 2014

XP-CR Tibial Tray - Interlok 91 mm Item # 195279

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

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