15 results · 20ms · Sources: EU EUDAMED, US FDA

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SENOVA(R) BLOOD GLUCOSE MONITOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496032076·MISS RELAX 70 SHEER, SIZE L, PAPRIKA, GRADUATED...

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120320761·Diamond, cylinder rounded edge, COOL DIAMANT, m...

PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FIRST CHOICE & FIRST CHOICE PLUS

FDA 510(k)
FDA Class 2 ·Neurology

UNK ASR 54 ACETABULAR CUP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 3, 2013

INTRINSIC

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code LWS·March 28, 2011

CONTOUR TEST STRIPS (50)

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·April 18, 2008

11.0MM TI HELICAL BLADE 10MM-STERILE

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·May 20, 2020

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 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

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018