13 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.

TSH RIASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Symmetry Rhoton®

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031490·Rhoton® Dissector, Straight Point Needle, Etche...

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209130177·

MILLENNIUM

FDA UDI
Avalign Technologies, Inc.·00190776355067·R-Type needle, straight,

LIFELINES PHOTIC STIMULATOR

FDA 510(k)
FDA Class 2 ·Neurology

INOMAX DS (DELIVERY SYSTEM)

FDA 510(k)
FDA Class 2 ·Anesthesiology

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MPRI·Product code LWS·August 9, 2016

SYMMETRY RHOTON

FDA Adverse Event
Malfunction ·SYMMETRY SURGICAL INC·Product code GZX·April 19, 2023

HT70 VENTILATOR

FDA Adverse Event
Injury ·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·April 25, 2014

GYNECARE X-TRACT MORCELLATOR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code HET·October 23, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

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