Company: Mako Surgical Corporation Date of Enforcement Report 11/28/12 Class ll: PRODUCT The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use...Read More

Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT 1. bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill...Read More

Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT 1. bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely...Read More

Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due...Read More

Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT bioMerieux BacT/ALERT Control Module, catalog number 200290,, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due...Read More

Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due...Read More