| 15 Jan 2019 | Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10 (81936) | Individual firm, name withheld | Drug | Class II | 1 |
| 15 Jan 2019 | HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe, Avella of Houston an FDA Registered 503B Outsourcing Facility 9265 Kirby Dr. Houston, TX 77054 (877) 794-0404 ---- NDC: 42852-725-65 | Advanced Pharma Inc. | Drug | Class II | 1 |
| 15 Jan 2019 | Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60. (81925) | Individual firm, name withheld | Drug | Class II | 1 |
| 8 Jan 2019 | 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644 (81913) | Happy Together, Inc. | Drug | Class I | 1 |
| 7 Jan 2019 | SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613 | Smith & Nephew, Inc. | Device | Class II | 1 |
| 7 Jan 2019 | Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 4 Jan 2019 | Elekta Unity | Elekta Limited | Device | Class II | 1 |
| 3 Jan 2019 | Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial]… | Sun Pharmaceutical Industries, Inc. | Drug | Class I | 2 |
| 2 Jan 2019 | Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 2 Jan 2019 | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52. | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 2 Jan 2019 | Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA | Lupin Pharmaceuticals Inc. | Drug | Class II | 2 |
| 2 Jan 2019 | Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy | Drug | Class II | 17 |
| 2 Jan 2019 | Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31 | Heritage Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 2 Jan 2019 | 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478. | PharMEDium Services, LLC. | Drug | Class II | 1 |
| 31 Dec 2018 | Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30 | Aurobindo Pharma USA Inc. | Drug | Class II | 10 |
| 28 Dec 2018 | 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth… | Fetzer Medical GmbH & Co. KG | Device | Class II | 4 |
| 26 Dec 2018 | Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, elec- tron… | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 26 Dec 2018 | Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 26 Dec 2018 | LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24 | Sun Pharmaceutical Industries, Inc. | Drug | Class III | 1 |
| 21 Dec 2018 | VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for… | Draeger Medical, Inc. | Device | Class I | 9 |
| 21 Dec 2018 | Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11. (81865) | Individual firm, name withheld | Drug | Class II | 1 |
| 20 Dec 2018 | OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07 | Allergan, PLC. | Drug | Class II | 1 |
| 20 Dec 2018 | Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ | Amerigen Pharmaceuticals Inc. | Drug | Class III | 2 |
| 20 Dec 2018 | Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA. | Lupin Pharmaceuticals Inc. | Drug | Class I | 4 |
| 19 Dec 2018 | Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA… | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 18 Dec 2018 | PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. | Ethicon, Inc. | Device | Class II | 1 |
| 17 Dec 2018 | BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. | Stryker Sustainability Solutions | Device | Class II | 1 |
| 17 Dec 2018 | DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician | DeRoyal Industries Inc | Device | Class II | 1 |
| 17 Dec 2018 | PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF). | Meridian Bioscience Inc | Device | Class II | 1 |
| 15 Dec 2018 | Eat Smart Salad Shake Ups - Asian Sesame/Sesame Asiatique; 5.5 oz. (156 g); UPC 7 09351-30241 1, 7 09351 30244 2 Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434 | Apio, Inc. | Food | Class I | 5 |
| 14 Dec 2018 | MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P,… | Bayer Medical Care, Inc. | Device | Class II | 1 |
| 13 Dec 2018 | Adam Bros. Family Farms Red Leaf Lettuce 24 heads per carton Adams Bros Family Farms and Ovation | Adam Bros. Farming, Inc. | Food | Class I | 3 |
| 12 Dec 2018 | Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed… | Ion Beam Applications S.A. | Device | Class II | 1 |
| 11 Dec 2018 | U by Kotex¿ Sleek¿, Regular Tampons, 18 Count | Kimberly-Clark Corporation | Device | Class II | 4 |
| 11 Dec 2018 | Del Monte Quality Fresh Cut Harvest Selects Fiesta Corn seasoned with Red & Green Peppers. NET WT 15.25 oz. (432 g); UPC 0 24000 02770; Ingredient: Vegetables (corn, red and green peppers) water, sea salt. Distributed by Del Monte Foods, Walnut Creek, CA 94598 | Del Monte Research Center - Walnut Creek | Food | Class II | 1 |
| 11 Dec 2018 | Sea Salt Caramels Tumbled In Milk Chocolate, Moonstruck brand. The product sold in an individual resealable plastic bag, net wt. 4 oz. The product is number is 312235 and the UPC code is 7 11175 12235 9. The product also sold in cardboard box of 8/4 oz. bags. The box has the SKU number 312235 and the UPC code… | Moonstruck Chocolate Company | Food | Class I | 1 |
| 7 Dec 2018 | LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or… | Waldemar Link GmbH & Co. KG (Mfg Site) | Device | Class II | 1 |
| 7 Dec 2018 | PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue. | Ethicon Endo-Surgery Inc | Device | Class II | 2 |
| 7 Dec 2018 | El Super Leon Jabalina Xtreme 50 pieces Net Wt. 2 lb. (3.2 oz.) Cont. Net. 1 kg packaged in a clear plastic jar, 6 jars per case | Procesadora de Dulces Tipicos, S.A. de C.V. | Food | Class I | 4 |
| 6 Dec 2018 | I-View¿ Contrast Enhanced Digital Mammography, ASY-08109 | Hologic, Inc. | Device | Class II | 1 |
| 4 Dec 2018 | MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery | Elekta, Inc. | Device | Class II | 1 |
| 4 Dec 2018 | BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use. | Waldemar Link GmbH & Co. KG (Mfg Site) | Device | Class II | 2 |
| 4 Dec 2018 | DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including… (81780) | Individual firm, name withheld | Device | Class II | 1 |
| 4 Dec 2018 | ROOT 23 CUCUMBER HABANERO SIMPLE SYRUP 375 ml (81761) | Root 23 LLC | Food | Class II | 1 |
| 3 Dec 2018 | Ingenia Elition S, Ingenia Elition X | Philips Medical Systems Nederlands | Device | Class II | 1 |
| 3 Dec 2018 | Hiland Chocolate Milk, 1/2 gallon (1.89 L). Hiland Dairy Springfield, MO 65803 | Hiland Dairy Foods Company LLC | Food | Class I | 1 |
| 1 Dec 2018 | MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician. | Canadian Hospital Specialties | Device | Class II | 1 |
| 30 Nov 2018 | Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 30 Nov 2018 | AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers. | Tosoh Bioscience Inc | Device | Class II | 6 |
| 29 Nov 2018 | Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61. | Advanced Pharma Inc. | Drug | Class I | 1 |
| 28 Nov 2018 | Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 28 Nov 2018 | Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1… | Boston Scientific Corporation | Device | Class III | 3 |
| 27 Nov 2018 | Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or… | Medical Action Industries Inc | Device | Class II | 1 |
| 21 Nov 2018 | Alinity i TSH Reagent Kit, List Number 07P4830 | Abbott Ireland Diagnostics Division | Device | Class II | 6 |
| 20 Nov 2018 | Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula… | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 19 Nov 2018 | SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution. | Randox Laboratories Ltd. | Device | Class II | 1 |
| 19 Nov 2018 | Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist | Arthrex, Inc. | Device | Class II | 1 |
| 16 Nov 2018 | Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip. | Cardinal Health Inc. | Device | Class II | 1 |
| 15 Nov 2018 | HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE | Howmedica Osteonics Corp. | Device | Class II | 2 |
| 15 Nov 2018 | Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use | GE Healthcare, LLC | Device | Class II | 1 |
| 14 Nov 2018 | ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as… (81749) | Swissray Medical AG | Device | Class II | 1 |
| 14 Nov 2018 | NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010 | In2bones USA, LLC | Device | Class II | 1 |
| 14 Nov 2018 | Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not… | Arrow International Inc | Device | Class II | 1 |
| 12 Nov 2018 | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 9 Nov 2018 | Perfusion Pack, Rx only, Sterile EO | LivaNova USA | Device | Class II | 1 |
| 9 Nov 2018 | Frozen Unbreaded Egg, 3 Cheese and caramelized onion. Sample Number 18-0115.01. Keep Frozen at 0-degrees or below zero. "Food for Research or Evaluation Use". Sargento Technical Center, Elkhart Lake, WI 53020 | Sargento Foods, Inc. | Food | Class II | 3 |
| 2 Nov 2018 | GEM Coupler Forceps, GEM4183C, packaged individually. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 2 Nov 2018 | curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1 Epi Safe Training Kit (8600-01102), Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health… | Bound Tree Medical, LLC | Drug | Class II | 4 |
| 1 Nov 2018 | Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency… | R & D Systems, Inc. | Device | Class III | 1 |
| 1 Nov 2018 | VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using… | ORTHO-CLINICAL DIAGNOSTICS | Device | Class II | 3 |
| 1 Nov 2018 | curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101) and 1 Epi Safe Training Kit (8600-01102), Rx Only. Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Producs, Inc. & Tri-anim… | Bound Tree Medical, LLC | Drug | Class II | 1 |
| 1 Nov 2018 | Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep Pads,1 Adhesive Dressing, 1 Insert. Distributed by Sarnova, HC. LLC's family companies: Bound Tree Medical. LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-amin Health Services,… | Bound Tree Medical, LLC | Drug | Class III | 1 |
| 30 Oct 2018 | Porcine Anorganic Bone Mineral 4.0cc | Collagen Matrix Inc | Device | Class III | 1 |
| 17 Oct 2018 | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic… | Volcano Corporation | Device | Class II | 2 |
| 16 Oct 2018 | iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101 | Conformis, Inc. | Device | Class II | 1 |
| 5 Oct 2018 | Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090 | ICU Medical, Inc. | Device | Class II | 3 |
| 3 Oct 2018 | Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International) | Medtronic Inc. | Device | Class II | 1 |
| 1 Oct 2018 | MEVION S250i | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 26 Sep 2018 | StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733068) Note: This… | Medtronic Navigation, Inc. | Device | Class I | 1 |
| 6 Sep 2018 | Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow. | Stihler Electronic Gmbh | Device | Class II | 3 |
| 12 Jul 2018 | Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Cool Mint REF/UP 4353 Rx… | Ultradent Products, Inc. | Device | Class II | 1 |
| 3 Jul 2018 | ABL800 analyzer, model numbers 393-800 and 393-801. | Radiometer America Inc | Device | Class II | 1 |
| 3 Jan 2018 | Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue… | Teleflex Medical | Device | Class II | 2 |
| 30 Oct 2017 | Discover VH/Millennium VG Nuclear Medicine Imaging System | GE Healthcare, LLC | Device | Class II | 2 |
| 17 Apr 2017 | EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01 | Syntho Pharmaceuticals, Inc. | Drug | Class II | 2 |