15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AXERA 2 ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CRYO.S
FDA UDI
Greiner Bio - One GmbH·14039943000511·
CRYO.S
FDA UDI
Greiner Bio - One GmbH·14039943002638·
3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
FDA 510(k)
FDA Class 2
·Dental
HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 29, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 17, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·August 12, 2008
BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 14, 2022
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code HBC·March 26, 2018
BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 28, 2022
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
FDA Recall
Terminated
·Concentric Medical Inc·Product code DQY·August 19, 2015
FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.
FDA Enforcement
Class II
·Terminated·Remington Medical Inc.·April 16, 2014
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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
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