12 results · 22ms · 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.

RAPID TOX CUP

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MERIT DRAINAGE DEPOT

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

ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752

FDA 510(k)
FDA Class 2 ·Hematology

LINEAR 3-4

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 12, 2021

WAVEWRITER ALPHA 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 1, 2024

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 29, 2011

RIATA ST ACTIVE FIXATION LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code DZI·October 6, 2020

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code DZI·July 15, 2025

NSK

FDA Adverse Event
Malfunction ·NAKANISHI INC.·Product code ELC·September 9, 2016

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