18 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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Fogg System Patient Monitoring Cables
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021067·FPS 2.7mm x 12mm Locking Screw
Plateau-V Spacer System
FDA UDI
Life Spine, Inc.·00190837028879·PLATEAU-V Interbody, Straight, Bulleted, 12mm x...
Plateau V & Z
FDA UDI
Life Spine, Inc.·00190837073435·Plateau V Spacer, 12mm x 22mm x 12mm,7 degree
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 15, 2023
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075268·FPS 2.7 x 12mm Locking Screw Sterile Qty 5
DIGITAL ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
HAND DRILL, MODEL 11-9901-7
FDA 510(k)
FDA Class 2
·Neurology
CAP FEMALE LUER LOK S/SU
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code KYW·August 22, 2024
BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·April 15, 2024
15X100MM KII OPTICAL ACCESS SYSTEM THREADED
FDA Adverse Event
Other
·APPLIED MEDICAL·Product code GCJ·July 26, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
2520274-2013-04220
FDA Adverse Event
Injury
·SYNTHES USA·Product code KTT·July 12, 2013
SYRINGE, IRRIGATING (NON DENTAL)
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code KYW·September 5, 2024
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
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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