Retiros de la FDA, julio 2014: 556 publicados

180 empresas distintas aparecen este mes.

Clasificación de riesgo: Class I: 55 · Class II: 464 · Class III: 37

Mismo mes, otras agencias:FSIS 7 retiros NHTSA 98 retiros

Retiros del mes

Fecha	Producto	Empresa
2 de julio de 2014	ANSPACH*Custom XMax Motor, PneumaticRx Only** This device is intended to be used…Z-1897-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	ANSPACH*REF 98-00087cm Medium Attachment CustomRx Only* This device is inten…Z-1884-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	ANSPACH*REF 98-0003Sagittal microSaw Attachment CustomRx Only* This device i…Z-1882-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	Floribbean Key Lime Calypso Dip 12.5 oz Floribbean 68 SW 40 St. Suite 411 Miami, Florida …F-2030-2014Miami Interculinary Center, Inc.	Miami Interculinary Center, Inc.
2 de julio de 2014	Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose …Z-1873-2014JAS Diagnostics Inc.	JAS Diagnostics Inc.
2 de julio de 2014	ANSPACH*eMax2 Lower Profile Foot PedalRx Only** This device is intended to be us…Z-1881-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)Z-1849-2014Western / Scott Fetzer Company	Western / Scott Fetzer Company
2 de julio de 2014	HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. …Z-1821-2014Nitinol Devices and Components, Inc.	Nitinol Devices and Components, Inc.
2 de julio de 2014	VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581Z-1842-2014Zimmer, Inc.	Zimmer, Inc.
2 de julio de 2014	California Grown Shelled Walnuts, Net Weight 12 oz (340g), UPC 69887507806 46 cases, 2…F-2048-2014Suntree LLC	Suntree LLC
2 de julio de 2014	ANSPACH*REF 98-0044Custom Device Speed Reducer with BumperRx Only* This devi…Z-1900-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reag…Z-1927-2014Siemens Healthcare Diagnostics, Inc	Siemens Healthcare Diagnostics, Inc
2 de julio de 2014	HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. …Z-1817-2014Nitinol Devices and Components, Inc.	Nitinol Devices and Components, Inc.
2 de julio de 2014	ANSPACH*REF 98-0024Nose Cone CoverRx Only* This device is intended to be use…Z-1891-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	ANSPACH*REF 98-0037Custom Device SC2102 with fast stop firmwareRx Only* This…Z-1896-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	ANSPACH*REF 98-0019Modified MDA Tube with MA-D20 AttachmentRx Only* This dev…Z-1888-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intend…Z-1844-2014Nellcor Puritan Bennett Inc. (dba Covidien LP)	Nellcor Puritan Bennett Inc. (dba Covidien LP)
2 de julio de 2014	ANSPACH*REF 98-00102.37mm Spiral Drill, for Short Attachment (Non-Sterile)**Rx Onl…Z-1885-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	Gouda Cheese wheels, Whole Wheels 10 lbs and Half Wheels 5 lbs., packaged under the the b…F-2049-2014Smith's Country Cheese, Inc.	Smith's Country Cheese, Inc.
2 de julio de 2014	RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy…Z-1851-2014Teleflex Medical	Teleflex Medical
2 de julio de 2014	ANSPACH*REF SP-3012-0013 mm Drill with Depth Stop for Short Heavy Duty Attachment**…Z-1905-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgi…Z-1871-2014Intuitive Surgical, Inc.	Intuitive Surgical, Inc.
2 de julio de 2014	Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for auto…Z-1847-2014Baxter Corporation Englewood	Baxter Corporation Englewood
2 de julio de 2014	LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses …Z-1866-2014LAP of America Laser Applications, LLC	LAP of America Laser Applications, LLC
2 de julio de 2014	Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 s…Z-1850-2014Steris Corporation	Steris Corporation
2 de julio de 2014	NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 La…Z-1854-2014NxStage Medical, Inc.	NxStage Medical, Inc.
2 de julio de 2014	DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALL…Z-1925-2014Biomet, Inc.	Biomet, Inc.
2 de julio de 2014	ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy Syst…Z-1846-2014VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH	VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
2 de julio de 2014	NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 La…Z-1860-2014NxStage Medical, Inc.	NxStage Medical, Inc.
2 de julio de 2014	ANSPACH*MA Attachment, Straight version CustomRx Only** This device is intended …Z-1883-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	ANSPACH*REF 98-0016eMax 2 Modified Hand ControlRx Only* This device is inten…Z-1887-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. …Z-1812-2014Nitinol Devices and Components, Inc.	Nitinol Devices and Components, Inc.
2 de julio de 2014	ANSPACH*REF 98-0012Shoulder Implant 011mm Rod, 20cm Long, CustomRx Only* Thi…Z-1918-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	ANSPACH*REF SP-3100-005mm Coarse Diamond Ball, 11.5 OALRx Only* This device …Z-1908-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgi…Z-1870-2014Intuitive Surgical, Inc.	Intuitive Surgical, Inc.
2 de julio de 2014	ANSPACH*REF-98-0056Custom Device Autolube III modified with a swivelRx Only* …Z-1903-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured…Z-1853-2014Nidek Inc	Nidek Inc
2 de julio de 2014	Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laborator…D-1408-2014Teva Pharmaceuticals USA	Teva Pharmaceuticals USA
2 de julio de 2014	NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 La…Z-1861-2014NxStage Medical, Inc.	NxStage Medical, Inc.
2 de julio de 2014	ANSPACH*REF 98-0035Custom eMax 2 Plus Motor with microMax Disconnect Sleeve**Rx Onl…Z-1895-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	ANSPACH*REF SP-3014-004mm Fluted Ball for MRIRx Only* This device is intend…Z-1907-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; …Z-1822-2014Nitinol Devices and Components, Inc.	Nitinol Devices and Components, Inc.
2 de julio de 2014	HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. …Z-1820-2014Nitinol Devices and Components, Inc.	Nitinol Devices and Components, Inc.
2 de julio de 2014	ANSPACH*REF 98-0001eMax Hand ControlRx Only* This device is intended to be u…Z-1880-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. …Z-1814-2014Nitinol Devices and Components, Inc.	Nitinol Devices and Components, Inc.
2 de julio de 2014	ANSPACH*Arthroscopic Knotless Suture AnchorRx Only** This device is intended to …Z-1915-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	ANSPACH*REF SP-3101-00Adjustable 25 Cm Mia Attachment, CustomRx Only* This d…Z-1909-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	ANSPACH*REF 98-0048Custom Circular ePLUS-FPRx Only* This device is intended …Z-1901-2014The Anspach Effort, Inc.	The Anspach Effort, Inc.
2 de julio de 2014	Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance…Z-1745-2014Philips Medical Systems (Cleveland) Inc	Philips Medical Systems (Cleveland) Inc
2 de julio de 2014	Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components…Z-1831-2014Beckman Coulter Inc.	Beckman Coulter Inc.

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