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U.S. Department of Health and Human Services

Medical Device Recalls

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Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128... 2 Apr-29-2016 Biosense Webster, Inc.
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205,... 2 Apr-29-2016 Biosense Webster, Inc.
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Compute... 2 Apr-29-2016 GE Medical Systems, LLC
The Livongo Health In Touch® Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) sy... 2 Apr-29-2016 Livongo Health
Analyst® MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/... 2 Apr-29-2016 Ab Sciex
MAKOplasty Hip Array Kit Laminate 150230 2 Apr-29-2016 Mako Surgical Corporation
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex M... 2 Apr-28-2016 Teleflex Medical
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpos... 2 Apr-28-2016 Mako Surgical Corporation
reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Ligh... 2 Apr-28-2016 LED Technologies, LLC
X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, ... 2 Apr-28-2016 Shimadzu Medical Systems

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