| 2 Nov 2015 | ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02 58872 EF Medica FS 50 LG 50359Ultragel FS50LG | Leonhard Lang Medizintechnik GmbH | Device | Class II | 1 |
| 2 Nov 2015 | Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class III | 1 |
| 28 Oct 2015 | Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal… | Medtronic Perfusion Systems | Device | Class II | 1 |
| 27 Oct 2015 | Cocoa buttons, item no. 80203, 80203-1, 25lb bulk case (72510) | Biscomerica, Inc. | Food | Class I | 1 |
| 27 Oct 2015 | Herr's Sour Cream & Onion Flavored Potato Chips (72516) | Herrs Foods Inc | Food | Class II | 1 |
| 26 Oct 2015 | MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence. (72552) | Astora | Device | Class II | 1 |
| 26 Oct 2015 | Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. | Par Pharmaceutical Inc. | Drug | Class III | 2 |
| 26 Oct 2015 | 7" Publix Bakery - German Chocolate Layer Cake. Product is shipped in cases containing 6 individual cakes. (72530) | Maplehurst Bakeries, LLC. | Food | Class I | 1 |
| 24 Oct 2015 | NatureBox Sticks 'n Stones; roasted nuts with sesame sticks 4.5 oz (128 g) pouches - UPC 8 52523 00546 4 and 5 lb. Corporate bags - no UPC; Ingredients: Sesame Sticks (unbleached flour, malted barley flour, soybean oil, sesame seeds, bulgar wheat, salt, beet powder, turmeric), Cashews, Almonds, Peanut Oil, Salt.… | NatureBox, Inc. | Food | Class II | 1 |
| 24 Oct 2015 | Mountain Mix 2oz bag, 7oz pouch, 10oz pouch, 17oz tin, 28oz pouch & 25lb bag. INGREDIENTS: Raisins, Peanuts (Peanuts, Peanut and/or Canola Oil, Salt), Choco Buttons (Sugar, Partially Hydrogenated Vegetable Oil [Contains One or More of the Following: Palm Kernel***Produced in a facility that processes peanuts and… | Kanan Enterprises, Inc. | Food | Class I | 3 |
| 23 Oct 2015 | Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080152 AMP253210152 AMP020080152 AMP025080002 AMP030040002 AMP030150152 AMP040120152 AMP335210152 AMP020120152… | Medtronic Vascular, Inc. | Device | Class II | 1 |
| 23 Oct 2015 | iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot. | Otto Bock Healthcare GmbH | Device | Class II | 1 |
| 23 Oct 2015 | Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis. | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 3 |
| 22 Oct 2015 | CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans | Innokas Medical Oy | Device | Class II | 1 |
| 21 Oct 2015 | CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers. | Civco Medical Instruments Co. Inc. | Device | Class II | 5 |
| 21 Oct 2015 | Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use. | Cook Inc. | Device | Class II | 1 |
| 21 Oct 2015 | Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10 | Breckenridge Pharmaceutical, Inc | Drug | Class III | 1 |
| 21 Oct 2015 | RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58. | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 20 Oct 2015 | 1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to… | Ameditech Inc | Device | Class II | 20 |
| 19 Oct 2015 | Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 19 Oct 2015 | FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is… | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 19 Oct 2015 | Kar's Sweet n' Salty Mix Box of 18, 3.5 oz. flexible film bags. 1 box per case. | Kar Nut Products Company | Food | Class II | 11 |
| 19 Oct 2015 | USFX Granny Smith Apples 175ct apples. Unit Size: Case/ Cardboard Carton, SKU 0244. (72489) | Northstar Produce | Food | Class II | 1 |
| 16 Oct 2015 | Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage. (72462) | Utah Medical Products, Inc | Device | Class II | 1 |
| 16 Oct 2015 | Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy. | Elekta, Inc. | Device | Class II | 1 |
| 16 Oct 2015 | ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term peripheral access to the central venous… | Arrow International Inc | Device | Class II | 1 |
| 16 Oct 2015 | L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Downing Labs, LLC | Drug | Class II | 48 |
| 15 Oct 2015 | Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 15 Oct 2015 | Martinelli's Gold Medal Sparkling Cider, 8.4 oz glass bottles; Packed in 12 pack, UPC 0 41244 00256; item number 12256; 4/6 packs, Tray UPC 0 41244-99932 3, item number 46256; 6 pack Retail UPC 0 41244 46256 8. Single 8.4 oz. bottle, UPC 041244 00256 6 | S. Martinelli & Co | Food | Class II | 4 |
| 15 Oct 2015 | Red Velvet Bundt Cake | My Dads Favorite Cookies, LLC | Food | Class II | 3 |
| 15 Oct 2015 | Krispy Kreme Doughnuts, Chocolate Iced Doughnuts with Kreme Filling, 2 count, Net Wt. 4.65oz, and Half Dozen, Net Wt. 16.2 oz., Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC 27102. | Krispy Kreme Doughnut Corporation | Food | Class II | 9 |
| 14 Oct 2015 | SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients… | Stryker Sustainability Solutions | Device | Class II | 1 |
| 14 Oct 2015 | SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and… | TZ Medical Inc. | Device | Class II | 1 |
| 14 Oct 2015 | Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity. | Teleflex Medical | Device | Class II | 1 |
| 14 Oct 2015 | Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03 | TZ Medical Inc. | Device | Class II | 1 |
| 14 Oct 2015 | Organic Coriander Powder (Dhania Powder), 60packs/case, UPC 40074 13813 (72419) | Nijay International, Inc. | Food | Class I | 1 |
| 14 Oct 2015 | Fresco Fresh Banana Strawberry Yogurt Parfait Net Wt. 6.5 oz. packaged in clear plastic tub. | Del Monte Fresh Produce N.A. | Food | Class I | 3 |
| 14 Oct 2015 | Granny Smith green apples, shipped in unmarked plastic bags and cardboard boxes. Sold individually in retail stores. (72433) | Del Monte Fresh Produce N.A., Incorporated | Food | Class I | 1 |
| 13 Oct 2015 | Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum. | Beckman Coulter Inc. | Device | Class II | 1 |
| 13 Oct 2015 | NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery. (72500) | Ceterix Orthopedics, Inc. | Device | Class II | 1 |
| 13 Oct 2015 | Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport. (72491) | Event Medical LTD | Device | Class I | 1 |
| 12 Oct 2015 | Dole All Natural SPINACH; Net Wt. 8 oz. (227 g). Enjoy by 10-15-15, UPC 7143000976 Product of the USA Excellent Source of Vitamin A, K, C, Folate and Manganese Distributed by Dole Fresh Vegetables, Monterey, CA | Dole Fresh Vegetables Inc | Food | Class I | 1 |
| 11 Oct 2015 | Ocean's Halo, The Seaweed Chip. Sea Salt Flavor; 2.5 oz. bag Organic and Gluten Free ingredients. USDA Organic. Outer Case UPC: 10851899005174 Unit (Bag) UPC: 8 51899 00517 7 Distributed by New Frontier Foods, Inc. Burlingame, CA. | New Frontier Foods/Ocean's Halo | Food | Class II | 3 |
| 9 Oct 2015 | miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair. (72386) | Miramar Labs, Inc. | Device | Class II | 1 |
| 9 Oct 2015 | SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. | CareFusion 303, Inc. | Device | Class II | 1 |
| 9 Oct 2015 | RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in… | Boston Scientific Corporation | Device | Class I | 2 |
| 9 Oct 2015 | Classic Baklava; Net WT 5.5 lbs (2.43 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 11930 Manufactured by Kronos Foods Corporation, Madera, CA | Kronos Foods, Inc. | Food | Class II | 8 |
| 8 Oct 2015 | Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute. (72449) | Precision Medical, Inc. | Device | Class II | 1 |
| 8 Oct 2015 | Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 7 Oct 2015 | ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 7 Oct 2015 | Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed | Hill-Rom, Inc. | Device | Class II | 1 |
| 7 Oct 2015 | Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place… | Synthes (USA) Products LLC | Device | Class II | 1 |
| 7 Oct 2015 | Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 | Cyberonics, Inc | Device | Class II | 1 |
| 7 Oct 2015 | Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release.… (72290) | Individual firm, name withheld | Device | Class II | 1 |
| 7 Oct 2015 | HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93. | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals | Drug | Class II | 1 |
| 7 Oct 2015 | Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Pacific Healthcare, Inc dba B&B Pharmacy | Drug | Class II | 16 |
| 7 Oct 2015 | Trader Joes Coconut Cranberry Granola (SKU 51131), packaged in a 16 oz. box, with Best By date 08/19/16 printed at the top of the package UPC Code: 0051 1315 printed on side panel. (72358) | New England Natural Bakers, Inc. | Food | Class I | 1 |
| 7 Oct 2015 | Organic Roquefort Papillon cheese packaged in clear plastic wrap | Whole Foods Market | Food | Class I | 1 |
| 6 Oct 2015 | 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 6 Oct 2015 | Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path | Baxter Healthcare Corp. | Device | Class II | 1 |
| 6 Oct 2015 | PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 | Chen Shwezin, Inc. dba Park Compounding Pharmacy | Drug | Class II | 5 |
| 6 Oct 2015 | American Pure Whey, Whey Protein Matrix Chocolate flavor, 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC. | American Pure Whey | Food | Class I | 6 |
| 5 Oct 2015 | Snack Out Loud Sea Salt Crunchy Bean Snacks 1.2 OZ Single Serve Units. (72348) | Fresca Foods, Incorporated | Food | Class I | 1 |
| 2 Oct 2015 | Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units | C.R. Bard, Inc. | Device | Class III | 1 |
| 2 Oct 2015 | Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic. | Focus Diagnostics Inc | Device | Class II | 1 |
| 2 Oct 2015 | Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY | Welch Allyn Inc | Device | Class II | 1 |
| 2 Oct 2015 | Nature's Eat Natural Macadamia Nuts NET WT 6 OZ (170g) in cello bags. | Texas Star Nut and Food Co., Inc. | Food | Class I | 2 |
| 2 Oct 2015 | Sunkist Frozen Mango Fruit Sorbet Bar 6 x 2.5 FL OZ. (74 mL) Bars/ 15 FL OZ (444 mL) and pint (473 mL) UPC: 51819-00303 | Dean Foods, Inc. | Food | Class I | 1 |
| 1 Oct 2015 | Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner. | WalkMed Infusion, LLC | Device | Class II | 1 |
| 1 Oct 2015 | Kontos Falafel Mix Net Wt. 5 LBS. (2.27kg) Distributed by Kontos Foods Inc., Paterson, New Jersey 07544 UPC 0-32394-7027-7 #70271 (72342) | Kontos Foods Inc. | Food | Class II | 1 |
| 1 Oct 2015 | Sobisk Lemon Cream Cookies; Imported Exclusively by: Sobisk Foods, LLC, 110 W Baltimore Ave, Clifton heights, PA 19018; Product of India;;; BEST BY: 1/31/2017 Net Wt: 11.04 oz package 10 Packs and/or Net Wt: 9.1 oz. 8 Packs. | Sobisk Foods LLC | Food | Class II | 3 |
| 30 Sep 2015 | BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic. | Becton, Dickinson and Company, BD Biosciences | Device | Class III | 1 |
| 30 Sep 2015 | Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table. | Shimadzu Medical Systems | Device | Class II | 1 |
| 30 Sep 2015 | Moonstruck Chocolates 9 piece Nuts & Chews Collection. The box contains 9 different nut and chews, various shapes, in 9 different flavors. Net Wt. 5.19oz (147g). Item Number: 310896, UPC: 7 11175 10896 4. | Moonstruck Chocolate Company | Food | Class II | 1 |
| 30 Sep 2015 | Baked Brie Herb/Garlic. An 8 ounce portion of Baked Brie wrapped in Phyllo Dough with garlic and herbs. Product shipped frozen, but sold thawed in a cheese case. UPC 2 17563 01499 7 | Market of Choice Inc. | Food | Class I | 1 |
| 29 Sep 2015 | Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the Triathlon MIS distal Resection Guide… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 29 Sep 2015 | TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811 (72434) | Tekia, Inc. | Device | Class II | 1 |
| 29 Sep 2015 | Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation… | Medtronic Inc. | Device | Class II | 1 |
| 29 Sep 2015 | MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization. | Biomet Spine, LLC | Device | Class II | 1 |
| 28 Sep 2015 | ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application. | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 28 Sep 2015 | VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600… | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 28 Sep 2015 | The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system… | GE Healthcare | Device | Class II | 2 |
| 25 Sep 2015 | Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients. (72413) | Individual firm, name withheld | Device | Class II | 1 |
| 24 Sep 2015 | MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 24 Sep 2015 | Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01 | Pfizer Inc. | Drug | Class II | 1 |
| 24 Sep 2015 | ON THE BORDER MEXICAN GRILL & CANTINA Cafe Style Tortilla Chips 18 oz. bags (72293) | Shearer's Foods Inc. | Food | Class I | 1 |
| 23 Sep 2015 | HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 23 Sep 2015 | Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System. (72425) | Individual firm, name withheld | Device | Class II | 1 |
| 23 Sep 2015 | MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS | GE Medical Systems, LLC | Device | Class II | 1 |
| 23 Sep 2015 | Ventilator Tubing | Instrumentation Industries Inc | Device | Class II | 1 |
| 23 Sep 2015 | Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation | Exactech, Inc. | Device | Class II | 1 |
| 22 Sep 2015 | Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed… | Integra LifeSciences Corp. d.b.a. Integra Pain Management | Device | Class II | 1 |
| 22 Sep 2015 | Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 22 Sep 2015 | Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310- Cholesterol, LDL (LDLL) | ELITech Clinical Systems SAS | Device | Class II | 4 |
| 22 Sep 2015 | Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma. | Sentinel CH SpA | Device | Class II | 1 |
| 22 Sep 2015 | Giant Red Mustard Hydroponic Micro Greens packaged in 2 oz. plastic hinged clamshell | Individual firm, name withheld | Food | Class I | 2 |
| 22 Sep 2015 | Evolution Fresh Nonfat Greek Yogurt with Strawberry and Granola, 6.1oz., UPC: 7 6211107474 4 (72257) | Greencore USA, Inc. | Food | Class I | 1 |
| 21 Sep 2015 | Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes… | Brainlab AG | Device | Class II | 1 |
| 21 Sep 2015 | Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure. | Alcon Research, Ltd. | Device | Class II | 1 |
| 18 Sep 2015 | Breaded Ravioli 10 lb. Mfg Foods R Us Scottsdale, AZ 85260 480-951-1883 (72262) | Foods R US | Food | Class I | 1 |
| 18 Sep 2015 | Florida Avocado, 14 count cardboard boxes. Invoice #5781, Sale P.O. #29899.438426.74307, Shipped Date 08/18/15 (72400) | Tropical Produce Specialist Corp | Food | Class I | 1 |
| 17 Sep 2015 | Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy. | Boston Scientific Corporation | Device | Class II | 1 |
| 16 Sep 2015 | Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella. | Encore Medical, Lp | Device | Class II | 1 |
| 16 Sep 2015 | CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System. | LifeHealth, LLC | Device | Class II | 2 |
| 15 Sep 2015 | Kermit's Key Lime Cocktail Sauce, 12 oz, Key West, FL, UPC 007172006076 & 0802468905503 | Kermit, Inc. | Food | Class II | 8 |
| 14 Sep 2015 | Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy. | NeuroLogica Corporation | Device | Class II | 1 |
| 14 Sep 2015 | MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. | CooperSurgical, Inc. | Device | Class III | 1 |
| 14 Sep 2015 | Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 6 |
| 14 Sep 2015 | Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck… | Encore Medical, Lp | Device | Class II | 2 |
| 14 Sep 2015 | PROVA, Standard Exhausted Vanilla Seeds, Graines VRAC, Caisses-outres of 50 X Lbs, packaged in a cardboard box. (72190) | Prova Inc | Food | Class II | 1 |
| 12 Sep 2015 | ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032. | US Compounding Inc | Drug | Class II | 59 |
| 10 Sep 2015 | VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 9 Sep 2015 | ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology. | Abbott Laboratories, Inc | Device | Class II | 1 |
| 9 Sep 2015 | Appeeling Fruit, Sweet Fresh, Apple Wedges, Net Wt. 16 oz. 8 2 oz. bags, UPC: 6 58324 08400, Best If Used By: 9/21/2015, Packed 6 - 8 unit packages/case; Appeeling Fruit, Sweet Fresh, Apple Wedges, Net Wt. 12 oz., , Best If Used By: 9/21/2015, Packed 6 packages/case; Produced by: Appeeling Fruit, Dauberville, PA 19533 | Appeeling Fruit, Inc | Food | Class I | 6 |
| 8 Sep 2015 | Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 8 Sep 2015 | Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members. | ErgoSafe Products, LLC (DBA) Prism Medical | Device | Class II | 2 |
| 8 Sep 2015 | Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This… | Biocare Medical, LLC | Device | Class II | 1 |
| 8 Sep 2015 | Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument. (72495) | Individual firm, name withheld | Device | Class II | 1 |
| 7 Sep 2015 | Earth Exotic Brussels Sprouts Net. Wt. 8 oz. (227 g) Net. Wt. 32 oz (2 LBS) 907 g (72195) | A.M.S. Exotic Llc | Food | Class I | 1 |
| 6 Sep 2015 | CU-W-Whole Cucumbers (1/6 CT Bag) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; Whole Cucumbers 1/5-LB NET WT: 5 LB Distributed by: US Foods, Inc. Rosemont, IL 60018 PRODUCE OF USA & MEXICO | Vaughan Foods | Food | Class I | 4 |
| 6 Sep 2015 | Cucumber, Super Select Unspecified variety packed in Hello Fresh box the week of August 24-28-2015 in the meal Spicy Tuna Tar-Tacos with Creamy Avocado and Cucumber Radish Slaw. 7-10 inches long, I cucumber per box. (72140) | Grocery Delivery E-Services USA, Inc. | Food | Class I | 1 |
| 4 Sep 2015 | EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use. | Dako North America Inc. | Device | Class II | 1 |
| 4 Sep 2015 | Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90. | Valeant Pharmaceuticals North America LLC | Drug | Class II | 1 |
| 4 Sep 2015 | Fat Boy Fresh Produce - cucumbers. Cucumbers are often referred to as Slicer or American cucumber and are 7-10 inches long ang 1.75 to 2.5 inches in diameter. Sold in cartons containing 24,cucumbers ; 6 cucumbers and 5 lbs of cucumbers. Additionally Super Select Fat Boy Label cucumbers are sold in cartons of 72 and… (72182) | Custom Produce Sales | Food | Class I | 1 |
| 4 Sep 2015 | Cucumber, sliced 3/8", product is packaged in a 2 lbs. plastic bag and placed in a cardboard box. Product is sold to deli department at retail store and it is not sold directly to consumers. The UPC is 0 45009 10104 4. | Triple B Corporation | Food | Class I | 1 |
| 4 Sep 2015 | 5/4 Limited Edition Cucumber Carton, Sizes 24SP, 36/36SP, 48. These cucumbers are shipped in a black, green, yellow, and craft colored carton which reads Limited Edition Pole Grown Cucumbers. This variety is often referred to as a Slicer or American cucumber. It has a dark green color. It typically has a length of 7… | Andrew & Williamson Fresh Produce | Food | Class I | 2 |
| 4 Sep 2015 | Raw cucumbers packaged in bulk in 6-count corrugated boxes bearing the Front Row Produce logo. There is no city or state listed on the label. (72142) | Front Row Produce LLC | Food | Class I | 1 |
| 3 Sep 2015 | AMSCO 400 and AMSCO C Small Steam Sterilizers | Steris Corporation | Device | Class III | 1 |
| 3 Sep 2015 | Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician. | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 3 Sep 2015 | BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton… | Bausch & Lomb Inc Irb | Device | Class II | 1 |
| 3 Sep 2015 | Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Drug | Class II | 39 |
| 3 Sep 2015 | Tradiciones Andinas Gourmet Foods Peeled Mote Corn, Mote Pelado, Net Wt. 15 oz. (425g), Product of Peru, Distributed By: JP Trading and Global Imports LLC, Newark NJ 07102 (72253) | JP Trading and Global Imports LLC | Food | Class II | 1 |
| 2 Sep 2015 | Sincerely Nuts brand Macadamia Nuts (Raw) (a) Whole, sold in 1 lb., 2 lb. and 5 lb. packages; (b) Unsalted Halves and Pieces sold in 2 lb. packages --- The product is packed in sealed flexible plastic packages and do not have UPC codes. (72075) | Individual firm, name withheld | Food | Class I | 1 |
| 1 Sep 2015 | IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed. | AGFA Healthcare Corp. | Device | Class II | 1 |
| 31 Aug 2015 | MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow… (72096) | Pyng Medical Corporation | Device | Class II | 1 |
| 31 Aug 2015 | DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01;… | DeRoyal Industries Inc | Device | Class II | 2 |
| 31 Aug 2015 | GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging. | GE Healthcare | Device | Class II | 7 |
| 28 Aug 2015 | ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 28 Aug 2015 | Frozen Peas & Carrots, Product is IQF, frozen, not ready to eat, each label carries cooking instructions. Product is packaged under the following brand names and sizes: 1. Bountiful Harvest, Net Wt.40 oz. (2.5 lbs.) 1.13 kg, UPC 22486-11902; 2. Giant Eagle, Net Wt 16 oz (1 lb) 454 g, UPC 30034-00993; 3. Our Family,… | Lakeside Foods, Inc | Food | Class II | 1 |
| 28 Aug 2015 | Frozen Corn distributed under the following labels and sizes: (a) WYLWOOD Super Sweet Whole Kernel Corn, NET WT. 16 OZ (1 LB), UPC 051933002401, DISTR. BY: SAVE-A-LOT FOOD STORES LTD. EARTH CITY, MO 63045; (b) MARKET BASKET Cut Corn, NET WT. 16 OZ. (1 LB.), UPC 049705693414, Packed Exclusively for: DEMOULAS… | Bonduelle USA Inc | Food | Class II | 1 |
| 28 Aug 2015 | Semi-Sweet Chocolate mini chips packaged in a plastic bad with yellow label and white lettering. (72191) | Enjoy Life Natural Brands | Food | Class III | 1 |
| 27 Aug 2015 | MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354. | The One Minute Miracle Inc | Drug | Class I | 2 |
| 26 Aug 2015 | The Great Gourmet 10/3 oz. Coconut seafood crab cake. | The Great Gourmet Inc | Food | Class II | 3 |
| 25 Aug 2015 | Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery. | Resource Optimization & Innovation Llc | Device | Class II | 8 |
| 25 Aug 2015 | Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure. | Resource Optimization & Innovation Llc | Device | Class II | 1 |
| 24 Aug 2015 | R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical. | Teleflex Medical | Device | Class II | 2 |
| 24 Aug 2015 | Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. (72013) | Perkin Elmer Life Sciences Inc | Device | Class II | 1 |
| 24 Aug 2015 | Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) NDC 24658-312-05 (side panel) (72304) | Individual firm, name withheld | Drug | Class II | 1 |
| 21 Aug 2015 | Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10 | Akorn, Inc. | Drug | Class III | 1 |
| 20 Aug 2015 | RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42. | Akorn, Inc. | Drug | Class III | 1 |
| 20 Aug 2015 | Hellmann's Zesty Italian Dressing, One Gallon (128 fl oz) 3.70 L (72203) | MCF Operating LLC | Food | Class I | 1 |
| 17 Aug 2015 | Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 2 |
| 17 Aug 2015 | CIOS ALPHA; image intensified fluoroscopic x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 14 Aug 2015 | Naturipe Foods Frozen Blueberries, IQF, 30 lb. boxes and 1500 lb. Totes, packed in cardboard boxes with plastic bag liners; 50 boxes per pallet or 1 Tote per pallet (72353) | MBG Marketing | Food | Class I | 1 |
| 13 Aug 2015 | Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood. | Nipro Medical Corporation | Device | Class II | 1 |
| 10 Aug 2015 | Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures. | Biomet 3i, LLC | Device | Class II | 2 |
| 6 Aug 2015 | LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd | Blue Square Market, Inc. | Drug | Class I | 2 |
| 5 Aug 2015 | Villa Sistemi Rotograph EVO 3D X-ray | Villa Radiology Systems LLC | Device | Class II | 2 |
| 24 Jul 2015 | ALPROSTADIL, Injectable Solution, 40 MCG/ML, 10 mL vials, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | JD & SN Inc., dba Moses Lake Professional Pharmacy | Drug | Class II | 101 |
| 24 Jul 2015 | Cold Smoked Salmon Deli trays (CS300), 2 pcs, 3lbs/trays. 6lbs per case. | Certified Smoked Fish LLC | Food | Class II | 2 |
| 16 Jul 2015 | Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures. | Mako Surgical Corporation | Device | Class II | 1 |
| 15 Jul 2015 | Italian Green Beans. Product is IQF frozen, not ready to eat, each label carries cooking instructions. Packages sizes: 14 oz.; 16 oz.; 2 lbs.; 2.5 lbs.; 20 lbs. and 1,350 lbs. (tote) Product is sold under brands: Birds Eye (C&W), Markson First Crop, Bountiful Harvest, River Valley, Simplot Classic, Sysco Classic,… | National Frozen Foods Corporation--Seattle | Food | Class II | 9 |
| 29 Jun 2015 | Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. | Baxter Healthcare Corp. | Device | Class III | 1 |
| 26 Jun 2015 | e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 22 Jun 2015 | c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR NEBULIZER, SOLUTIONS Rx PHARMACY, 2705 4TH AVENUE SOUTH, BIRMINGHAM, AL 35233 (72592) | Solutions Rx Pharmacy | Drug | Class II | 1 |
| 17 Jun 2015 | Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures. | ConMed Corporation | Device | Class II | 1 |
| 28 May 2015 | Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch) (72390) | Barco Inc. | Device | Class II | 1 |
| 20 May 2015 | AKSAR (life taste and beyond) Cashew Pieces 4040615 Net Wt: 7oz (200gm) , Net Wt: 28oz (800gm) 4051315 Net Wt: 400 gms (14oz) , Net Wt: 5lb 20 NEWLAND COURT, STERLING, VA 20165 Phone # 703-880-9802 , FAX # 703-880-1602 (71309) | Aksar LLC | Food | Class I | 1 |
| 19 May 2015 | HUA ZHI YING GOURD CANDY, 250G(8.8oz), each carton is packed with 40/250G units, An Shun Trading Co., LTD 4425B 1st AVE BROOKLYN, NY 11232 (718) 509-9558 (72359) | A & S Food Trading Inc. | Food | Class I | 1 |
| 8 May 2015 | BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery. | Brainlab AG | Device | Class II | 1 |
| 5 May 2015 | ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 17 Apr 2015 | GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery | Medacta Usa | Device | Class II | 1 |
| 10 Mar 2015 | BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | the Compounder | Drug | Class II | 47 |
| 13 Feb 2015 | Goya Mojo Criollo Marinade for Chicken, Pork & Beef (a) 12 ounce (b) 24.5 oz and (c) 1 Gallon containers; Goya Foods, Inc., Secaucus, NJ 07096 USA Distributor. Product of Dominican Republic | Goya Foods | Food | Class II | 2 |
| 23 Dec 2014 | HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 19 Nov 2014 | ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+ | Philips Electronics North America Corporation | Device | Class II | 1 |
| 19 Nov 2014 | Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 19 Nov 2014 | Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 22 Apr 2014 | HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients | Hamilton Medical, Inc. | Device | Class I | 1 |
| 5 May 2012 | Robotic hand accessory to InMotion Arm, rehabilitation robot. (72326) | Interactive Motion Technologies, Inc. | Device | Class II | 1 |
| 1 May 2008 | GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |