17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SM-EXTRA WIDE (RBM) IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ACTERA FEMORAL REUSABLE INSTRUMENT TRAY
FDA UDI
Conformis, Inc.·00810933031695·ACTERA FEMORAL REUSABLE INSTRUMENT TRAY
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482140246·Rhoton Bipolar Forceps; Bayonet; Titanium; 1.5 ...
Slimplicity Anterior Cervical Plate System
FDA UDI
PRECISION SPINE, INC.·00815362021163·1 Level 28mm Plate
NOBELACTIVE INTERNAL RP 4.3X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 17, 2020
NOBELACTIVE INTERNAL NP 3.5X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·September 9, 2020
NOBELACTIVE INTERNAL NP 3.5X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·September 9, 2020
NOBELACTIVE INTERNAL RP 4.3X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 17, 2020
COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
HARDYDISK, CEFAZOLIN, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·April 26, 2013
UNKNOWN DEPUY FEMORAL COMPONENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSA·July 18, 2008
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 6, 2011
E-POLY TIBIAL BEARINGS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·July 12, 2017
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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