10 results · 19ms · Sources: EU EUDAMED, US FDA

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BAROguard

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

INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S

FDA 510(k)
FDA Class 2 ·General Hospital

SYSTEM 100 ULTRAFILTRATION CATHETER

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

CLEARLINK BURETROL SOLUTION SETS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 13, 2023

ISOFLEX LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

KINETRA

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 18, 2011

SLIMPORT LOW-PROFILE DUAL-LUMEN IMPLANTABLE PORT WITH ATTAC

FDA Adverse Event
Injury ·C. R. BARD INC. (BASD)·Product code LJT·July 10, 2013

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026