Core noun
Recalled products
The canonical enforcement rows. Everything else groups, enriches, or interprets these records.
Indexed record set
86,536 products
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- Product
- Product is a liquid dietary supplement packaged in white plastic bottles with a shrink wrap sleeve label. The product comes in 3 sizes, 2 oz, 16oz. and 33.8oz. The product label reads in part: "Fast Absorbing Liquid 1-OZ A DAY***WELLESSE***Digestive 3-in-1 Health Soluble Fiber Prebiotics Aloe Vera Promotes Gentle Regularity Supports Health Bacteria Balances Stomach Acidity***Isomaltooligosaccharides (Prebiotic Fiber),***Galactooligosaccharides***Other Ingredients: Purified Water***Manufactured By: Botanical Laboratories, Inc. Ferndale, WA 98248 USA***"
- Firm
- Botanical Laboratories Inc
- Event
- Event 62058
- Initiated
- June 04, 2012
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- Product
- Korean Molluscan Shellfish (Seasoned Oysters) 250kg, 1000kg
- Firm
- Hamchorom Inc.
- Event
- Event 62294
- Initiated
- June 04, 2012
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- Product
- Queso Pringles, 40 g , and Cont. Neto Net Weight: 139 g( 4.9 oz) Queso /Cheese; Busting with more Flavor "Ahora con Man Sabor"
- Firm
- Kellogg Company
- Event
- Event 62274
- Initiated
- June 04, 2012
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- Product
- half shell Oysters, 144pc/cs
- Firm
- Ocean Group Inc.
- Event
- Event 61999
- Initiated
- June 02, 2012
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- Product
- Large IQF Oysters, 6 x 4 lb/cs
- Firm
- Ocean Group Inc.
- Event
- Event 61999
- Initiated
- June 02, 2012
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- Product
- Tiny IQF Oysters, 40pk/cs, 8oz.
- Firm
- Ocean Group Inc.
- Event
- Event 61999
- Initiated
- June 02, 2012
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- Product
- I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
- Firm
- I-Flow LLC
- Event
- Event 64826
- Initiated
- June 01, 2012
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- Product
- I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
- Firm
- I-Flow LLC
- Event
- Event 64826
- Initiated
- June 01, 2012
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- Product
- Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
- Firm
- PSC Industries Inc
- Event
- Event 61958
- Initiated
- June 01, 2012
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- Product
- Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
- Firm
- PSC Industries Inc
- Event
- Event 61958
- Initiated
- June 01, 2012
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- Product
- Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
- Firm
- PSC Industries Inc
- Event
- Event 61958
- Initiated
- June 01, 2012
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- Product
- T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
- Firm
- Stryker Instruments Div. of Stryker Corporation
- Event
- Event 61848
- Initiated
- June 01, 2012
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- Product
- Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
- Firm
- PSC Industries Inc
- Event
- Event 61958
- Initiated
- June 01, 2012
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- Product
- Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
- Firm
- PSC Industries Inc
- Event
- Event 61958
- Initiated
- June 01, 2012
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- Product
- Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.
- Firm
- PSC Industries Inc
- Event
- Event 61958
- Initiated
- June 01, 2012
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- Product
- T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
- Firm
- Stryker Instruments Div. of Stryker Corporation
- Event
- Event 61848
- Initiated
- June 01, 2012
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- Product
- Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method.
- Firm
- Sysmex America, Inc.
- Event
- Event 62580
- Initiated
- June 01, 2012
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- Product
- Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
- Firm
- Sysmex America, Inc.
- Event
- Event 62580
- Initiated
- June 01, 2012
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- Product
- Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
- Firm
- Sysmex America, Inc.
- Event
- Event 62580
- Initiated
- June 01, 2012
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- Product
- CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01
- Firm
- Bracco Diagnostics Inc
- Event
- Event 62866
- Initiated
- June 01, 2012