22 results · 31ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MC3 Crescent Jugular Dual Lumen Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDINAL HEALTH

FDA UDI
Cardinal Health 200, LLC·10192253065282·Cardinal Health Esmark Bandage

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113844·VISCO CANNULA 21GA ANGLE 8MM

CARDINAL HEALTH

FDA UDI
Cardinal Health 200, LLC·10885380114748·Cardinal Health Esmark Bandage

Arena-C®

FDA UDI
SPINEFRONTIER, INC.·00190361036852·Trial Rasp, No Stop, Assembly, Lordotic, 9mm

HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

ELECSYS FSH CALSET II

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

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

AUTOCAT2 WAVE

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DSP·October 17, 2008

CAPSUREFIX

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 2, 2013

CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

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

Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

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

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021