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

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RevCore™ Thrombectomy Catheter.

FDA 510(k)
FDA Class 2 ·Cardiovascular

MERIT HYDROPHILIC GUIDE WIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

SILVERLON ADHESIVE STRIP

FDA 510(k)
FDA Unclassified ·Unknown

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 26, 2025

CLEARLINK CONTINU-FLO SOLUTION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 22, 2023

CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 24, 2022

CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 4, 2022

CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 24, 2022

MARQUIS VR

FDA Adverse Event
Death ·MEDTRONIC S.A.·Product code LWS·August 25, 2011

TRUERESULT

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code LFR·August 5, 2014

AMPHIRION DEEP PTA BALLOON CATHETER

FDA Adverse Event
Injury ·INVATEC SPA·Product code DQY·July 12, 2013

CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 14, 2022

MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

FDA Enforcement
Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

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