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

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SYMBIOS DISPOSABLE INFUSION PUMP KIT

FDA 510(k)
FDA Class 2 ·General Hospital

POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

TERUMO U-100 INSULIN SYRING

FDA 510(k)
FDA Class 2 ·General Hospital

SEDLINE KIT

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·November 25, 2025

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 10, 2013

CLINICAL INFORMATION CENTER

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code DRT·May 21, 2008

CAPSURE SP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

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

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024