13 results · 27ms · Sources: EU EUDAMED, US FDA

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NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA

FDA 510(k)
FDA Class 1 ·Hematology

Precept

FDA UDI
Nuvasive, Inc.·00887517401342·PRECEPT Loading Block, Leg

Symmetry Hardy

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482030714·Symmetry® Curette, Hardy, Angled Up, 3 mm Tip W...

KONG-C VBR M, Body, 46 mm

FDA UDI
icotec AG·07640164849836·KONG-C VBR M, Body, 46 mm

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX

FDA 510(k)
FDA Class 2 ·Cardiovascular

HOYA IS INJECTOR SYSTEM

FDA 510(k)
FDA Class 1 ·Ophthalmic

FORTIFY DR, DF4 CONNECTOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 8, 2014

STENOSCOP

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 18, 2012

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 21, 2007

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

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

PROPONENT DR SL (Model L201)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

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