13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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