18 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Phacoemulsification Needle (Tip) and Irrigation Sleeve
FDA 510(k)
FDA Class 2
·Ophthalmic
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799000385·
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304512061·
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260797·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198710·AK3 Ultra Insert Trial Size 4, 18mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694009713·2.4mm x 18mm Cannulated Lag Screw
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973108139·TRIAL 90-SRK-192418 POLY-MPCS 4X18 LEFT
OsteoMed
FDA UDI
OSTEOMED LLC·00845694070706·Cannulated 2.4 x 18mm Lag Screw Sterile Qty 5
REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ENTRACARE GASTROSTOMY FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IOLMASTER 500
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL INC.·Product code KDI·October 7, 2008
TARGET 360 ULTRA 1.5 MM X 2 CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR CORK·Product code HCG·June 27, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·August 5, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018
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
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