| 15 May 2025 | BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX… | CareFusion 213, LLC | Drug | Class II | 1 |
| 14 May 2025 | Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP),… Event 96857 | AsttraZeneca Pharmaceuticals LP | Drug | Class II | 1 |
| 13 May 2025 | Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146 | Philips North America Llc | Device | Class II | 18 |
| 13 May 2025 | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94 | Zydus Pharmaceuticals (USA) Inc | Drug | Class II | 2 |
| 9 May 2025 | Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01. | KVK Tech, Inc. | Drug | Class II | 2 |
| 9 May 2025 | Zeke's Daddy's Granola; INGREDIENTS: Whole grain rolled oats, maple syrup, expeller pressed canola oil, coconut, brown sugar, molasses, cinnamon, salt, natural flavor; Contains coconut; Manufactured in a facility that uses peanuts, tree nuts, soy, wheat, sesame, and milk; 30 LBS; ACAI GUYS Event 96864 | BBF Massachusetts LLC | Food | Class I | 1 |
| 8 May 2025 | Dixit Foods, Sabudana Khichadi, Net Wt. 200 g, Ingredients: Sago (Sabudana), Crushed Groundnuts, Sugar, DesiGhee, Salt, Green Chilli, Cumin Seeds. Allergen Information: May contain Peanuts, Treenuts, Wheat, Sesame, Mustard | Bondsforever, Inc dba Shastha Foods | Food | Class II | 2 |
| 7 May 2025 | Organic traditions brand JUMBO PUMPKIN SEEDS; 227 g; 8 oz; Packaged and Distributed by: Advantage Health Matters Inc.; UPC: 6 27733 00175 5 Event 96852 | Advantage Health Matters Inc. | Food | Class I | 1 |
| 6 May 2025 | PhenoMATRIX Event 96765 | Name withheld | Device | Class II | 1 |
| 2 May 2025 | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2 | ICU Medical, Inc. | Device | Class II | 1 |
| 2 May 2025 | Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364. Event 96808 | Empower Clinic Services, LLC dba Empower Pharmacy | Drug | Class II | 1 |
| 2 May 2025 | Yellowstone Brown Sugar Molasses Baked Beans, NET WT. 15 OZ (425g), packaged in cans, packed 12 cans per case. UPC: 071846187071; Packaged by: Vietti Foods Inc. Nashville, TN 37203 Event 96819 | Vietti Acquisitions, LLC | Food | Class I | 1 |
| 30 Apr 2025 | Tomatoes, retail 4 Count Vine Ripe Tomatoes packaged in clam shell containers [20 oz. (1 lb. 4 oz) 567g] with UPC# 7 96553 20062 1; 12 retail clam shells per case. Bulk 25# 6x6 tomatoes (cardboard case), bulk 10# 6x6 Tomatoes (cardboard case), bulk 25# Random #2 Tomatoes (cardboard case), bulk 20# 5x6 Vine Ripe… Event 96816 | Ray & Mascari,Inc | Food | Class I | 1 |
| 29 Apr 2025 | H&C Farms Raw Premium Tomatoes, Naturally Grown from Seed Net WT 25 Lbs., 11.34 KG, packaged in cardboard box with lid, multiple packaging sizes of tomatoes: JUMBO PER BOX 38-42 TOMATOES, 5X6 PER BOX 55-62 TOMATOES, 6X6 PER BOX 75-82 TOMATOES, 6X7 PER BOX 85-92 TOMATOES. REFRIGRERATE Event 96803 | Hanshaw & Capling Farms, LLC | Food | Class I | 1 |
| 28 Apr 2025 | Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus… | Abbott Molecular, Inc. | Device | Class II | 2 |
| 28 Apr 2025 | temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01. Event 96763 | Siddha Flower Essences, LLC. | Drug | Class II | 1 |
| 28 Apr 2025 | TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01 | BSO LLC | Drug | Class II | 5 |
| 26 Apr 2025 | Trader Joe's Sesame Miso Salad with Salmon, net wt. 10.25oz., in clear plastic clamshell container, UPC 00773164 Event 96795 | Taylor Farms Illinois Inc. | Food | Class I | 1 |
| 25 Apr 2025 | Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01 | Mckesson Medical-Surgical Inc. Corporate Office | Drug | Class II | 2 |
| 25 Apr 2025 | Lactoferrin as Apolactoferrin 60 vegetarian capsules, 300 mg per serving. UPC 8 50062 61315 7. Amazon ASIN #B0DNLMBHGG. Event 96749 | My Life Inc | Food | Class I | 1 |
| 25 Apr 2025 | Rocky Road Flavored Ice Cream, 3 GAL, Wells Enterprises, INC dba Wells Dairy, Inc Le Mars, IA 51031, UPC: 070640050314, Item: 19695 | Wells Enterprises, Inc. | Food | Class II | 22 |
| 24 Apr 2025 | Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS | Baxter Healthcare Corporation | Device | Class I | 1 |
| 24 Apr 2025 | Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-030-05, UPC 8 10096 77151 3. | KENIL HEALTHCARE PRIVATE LIMITED | Drug | Class II | 20 |
| 23 Apr 2025 | Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15. | BRS Analytical Services, LLC | Drug | Class II | 5 |
| 23 Apr 2025 | PRESIDENT BRAND; Kumquat Slices; NET WT. 8 OZ/227g; EAST CK TRADING INC.; INGREDIENTS: Kumquat slices; packaged in clear plastic jars with UPC 8 10077 20936 3 Event 96813 | East CK Trading Inc. | Food | Class II | 1 |
| 23 Apr 2025 | New England Village Snacks The 19th Hole Snack Mix (5 oz. and 10 oz.) Event 96758 | Better Business...Better Foods, Inc. | Food | Class II | 1 |
| 22 Apr 2025 | Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35 | Ethicon Endo-Surgery Inc | Device | Class I | 1 |
| 22 Apr 2025 | Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02 | RemedyRePack Inc. | Drug | Class II | 1 |
| 21 Apr 2025 | BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 Event 96734 | Numed Inc | Device | Class II | 1 |
| 21 Apr 2025 | BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862 | Becton Dickinson Infusion Therapy Systems, Inc. | Device | Class II | 1 |
| 21 Apr 2025 | Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01 | Eugia US LLC | Drug | Class II | 2 |
| 21 Apr 2025 | Ankimo branded Monkfish Liver; NET WT. 7 OZ (200g); Imported and DIST. BY: JJWV Marketing Corporation; Santa Fe Springs, CA 90670 USA; UPC# 8 94042 00256 2 Event 96757 | JJWV Marketing Corporation | Food | Class I | 1 |
| 19 Apr 2025 | Item M7204, frozen foodservice Lamb Weston Hashbrown Patties, frozen, LW Formed Oval 6/3.5LB bags per case. GTIN*10044979923813. Made in USA. | LAMB WESTON Inc | Food | Class II | 4 |
| 18 Apr 2025 | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01. | American Regent, Inc. | Drug | Class II | 2 |
| 18 Apr 2025 | Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03. | Preferred Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 18 Apr 2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01. | FDC Limited | Drug | Class II | 1 |
| 17 Apr 2025 | Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357) | Cook Incorporated | Device | Class II | 1 |
| 17 Apr 2025 | Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686, | Cook Incorporated | Device | Class II | 2 |
| 17 Apr 2025 | Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber | C.R. Bard Inc | Device | Class I | 5 |
| 17 Apr 2025 | Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box) | Amneal Pharmaceuticals, LLC | Drug | Class I | 1 |
| 17 Apr 2025 | Beijing Soybean Paste, packaged in 8.82 ounce/250g red and white packages; Ingredients Soybean, Flour, Salt, Water, Potassium Sorbate; UPC: 6917799000385 Event 96717 | May Flower International Inc | Food | Class II | 1 |
| 17 Apr 2025 | Mild Salsa is refrigerated product, packaged in Polypropylene container, net wt. 14oz, UPC 1 18738 54632. San Juan Salsa Co. Arlington, WA 98223, www.sanjuansalsa.com | Frobright Salsary, LLC | Food | Class II | 8 |
| 16 Apr 2025 | National brand Kasundi PEELED MANGO PICKLE IN OIL; Net Wt.: 1 Kg (35.27 oz)/ 2.20lb; Ingredients: Kasundi (Peeled Mango), Canola Oil, Cabbage, Salt, Mixed Spices, Vinegar, Sodium Benzoate as preservative; Product of Pakistan; packaged in a plastic jar with a red lid Event 96725 | Advance Food International Inc. | Food | Class II | 1 |
| 16 Apr 2025 | Enoki Mushroom in a 200g, green plastic package marked with UPC Barcode 6975730520101 on the back label and labeled as distributed by Hofood99 Inc., 21903 56th Ave Oakland Gardens, NY 11364 Event 96724 | HARVEST NYC INC | Food | Class I | 1 |
| 15 Apr 2025 | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007 | Remote Diagnostic Technologies Ltd. | Device | Class II | 1 |
| 15 Apr 2025 | Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial). Event 96699 | Nubratori, Inc | Drug | Class II | 1 |
| 15 Apr 2025 | FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25 | Apollo Care, LLC | Drug | Class II | 1 |
| 15 Apr 2025 | Bone & Joint Restore. 180 capsules in a plastic bottle. Shelf life two years. Store at ambient temperature. Optimal Carnivore LLC 1603 Capitol Ave Ste 310 WY371 Cheyenne, WY 82001 Event 96713 | Optimal Carnivore, LLC | Food | Class I | 1 |
| 14 Apr 2025 | Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. Event 96686 | Augmedics Ltd. | Device | Class II | 1 |
| 14 Apr 2025 | La Victoria Cilantro Salsa; Med; Net Wt 15.5 OZ; UPC# 0 72101 34470 3; Distributed by: Megamex Foods, LLC Orange, CA 92868 Event 96712 | MegaMex Foods LLC | Food | Class II | 1 |
| 12 Apr 2025 | Outer carton labeled: "Cookie Butter Banana Pie" Inner carton labeled: "Tropical Key Lime Pie" Product contained inside: "Cookie Butter Banana Pie" NET WT. 11 LB 2.8 OZ (5.06 kg) GROSS WT: 12.96 LB (5.88 kg) Event 96704 | Name withheld | Food | Class II | 1 |
| 12 Apr 2025 | Multigrain Sourdough Freshly Backed, and Half Multigrain Sourdough Artisan Bread, 15 oz; 7 oz, Bag, 1 unit | Giant Eagle, Inc. | Food | Class II | 1 |
| 12 Apr 2025 | Ancient Grains Hoagie Roll, 4 oz, Paper carton (corrugated), CP45, Frozen | Upper Crust Bakery LP | Food | Class II | 3 |
| 11 Apr 2025 | MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case). | Nipro Renal Soultions USA, Corporation | Device | Class I | 1 |
| 11 Apr 2025 | TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J. | LeMaitre Vascular, Inc. | Device | Class II | 3 |
| 11 Apr 2025 | iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle. | Medical Depot Inc. | Device | Class I | 1 |
| 11 Apr 2025 | CODMAN Disposable Perforator, 14mm. Cranial perforator. | Integra LifeSciences Corp. (NeuroSciences) | Device | Class I | 2 |
| 11 Apr 2025 | Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter Event 96697 | Centerline Biomedical Inc | Device | Class I | 1 |
| 11 Apr 2025 | Emily Kate's Gluten Free Vanilla Cake, Net Wt. 6.4oz, Emily Kate's Foods, Kansas City, KS 66106, UPC 850581007253 | Emily Kate's Foods | Food | Class II | 2 |
| 10 Apr 2025 | CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH,… | Smiths Medical ASD, Inc. | Device | Class I | 1 |
| 10 Apr 2025 | CMS8000 Patient Monitor Event 96046 | Contec Medical Systems Co., Ltd. | Device | Class II | 1 |
| 10 Apr 2025 | Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement. Event 96651 | Name withheld | Device | Class II | 1 |
| 10 Apr 2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a ventilator. | Vyaire Medical | Device | Class I | 2 |
| 10 Apr 2025 | CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 4) PUMP KIT,… | Smiths Medical ASD, Inc. | Device | Class I | 2 |
| 10 Apr 2025 | CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR… | Smiths Medical ASD, Inc. | Device | Class I | 2 |
| 10 Apr 2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17 | ACCORD HEALTHCARE, INC. | Drug | Class II | 4 |
| 9 Apr 2025 | PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager). | Richard Wolf GmbH | Device | Class II | 1 |
| 9 Apr 2025 | FoundationOne Companion Diagnostic (F1CDx) | Foundation Medicine, Inc. | Device | Class II | 1 |
| 9 Apr 2025 | Centurion Sterile Weitlaner Retractor, Reorder: 67315 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 2 |
| 9 Apr 2025 | Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14. | Cardinal Health Inc. | Drug | Class II | 1 |
| 8 Apr 2025 | Artix MT Thrombectomy Device, REF: 32-102 Event 96682 | Inari Medical - Oak Canyon | Device | Class II | 1 |
| 7 Apr 2025 | IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. | Philips Medical Systems Nederland B.V. | Device | Class II | 1 |
| 7 Apr 2025 | Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line High Humidity… | Philips North America Llc | Device | Class II | 1 |
| 7 Apr 2025 | Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity) Event 96632 | Name withheld | Device | Class II | 1 |
| 7 Apr 2025 | Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US | Ambu Inc. | Device | Class II | 1 |
| 7 Apr 2025 | Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP. | Baxter Healthcare Corporation | Device | Class I | 2 |
| 5 Apr 2025 | Heinen's Honey Roasted Peanuts, NET WT 8.25 OZ (234g), packaged in a composite can with plastic lid, 12 cans per case, Best If Used By: 10/01/2025 and Best By: 10/03/2025, UPC: 020601401877, Distributed By: Heinen's, Inc., Warrensville Hts., OH 44128 Event 96663 | Trophy Nut Company | Food | Class I | 1 |
| 4 Apr 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component:… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 4 Apr 2025 | INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter. | Integra LifeSciences Corp. (NeuroSciences) | Device | Class II | 1 |
| 4 Apr 2025 | KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the… | Name withheld | Device | Class II | 2 |
| 4 Apr 2025 | Blueberry Lemon Scones, bulk packaged in bakery boxes. Products are sold at retail in pastry cases and not individually labeled. Event 96788 | The Hot Chocolatier - St. Elmo, LLC | Food | Class II | 1 |
| 3 Apr 2025 | Enhanced Verify Evaluation Handset (CFN HH90130FA) Event 96688 | Name withheld | Device | Class II | 1 |
| 3 Apr 2025 | Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 880-303/21 (Sz. 3-4 - cemented lg), (8)… | Waldemar Link GmbH & Co. KG (Mfg Site) | Device | Class II | 4 |
| 3 Apr 2025 | Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator. Event 96635 | WANDERCRAFT SAS | Device | Class II | 1 |
| 3 Apr 2025 | Sundae Shoppe, Cookies and Cream Mochi Ice Cream, 6 count, 7.5 oz, Plastic sealed tray inside paper carton. 6 Pieces per carton, 8 cartons per shipper. Keep frozen. Event 96652 | Gordon Desserts DBA Mochidoki | Food | Class II | 1 |
| 3 Apr 2025 | CHILE VERDE EGG BITES; NET WT. 4.6 OZ (130 g); 2 egg bites/package Event 96733 | Valley Fine Foods Co., Inc | Food | Class II | 1 |
| 2 Apr 2025 | HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples. Event 96612 | Leica Biosystems Melbourne Pty Ltd | Device | Class II | 1 |
| 2 Apr 2025 | Washer Disinfector Aquadis 56; Model Number: 56A | Getinge Disinfection Ab | Device | Class II | 2 |
| 2 Apr 2025 | Caraluzzi's Italian Style Seafood Burgers, 8oz; INGREDIENTS: Cod, Salmon, Shrimp, Scallops, Onions, Olive Oil, White Wine, Parsley, Sodium Caseinate (A Milk Derivative), Spices, Garlic, Salt, Paprika, Enzyme.; CONTAINS: Crustacean Shellfish, Fish, Milk; Distributed by Caraluzzi's Markets, Bethel, CT 06801; UPC: 0… Event 96670 | Caraluzzi's Markets | Food | Class I | 1 |
| 1 Apr 2025 | myQA iON; Article Number: MQ10-000; | IBA Dosimetry GmbH | Device | Class II | 1 |
| 31 Mar 2025 | Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. | Siemens Healthcare Diagnostics Inc | Device | Class II | 1 |
| 31 Mar 2025 | Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and HP Procedure Pack (P/N 902-00048P). The three… | Belmont Instrument LLC | Device | Class II | 3 |
| 31 Mar 2025 | 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the same case for shipment. The female quick… | Belmont Instrument LLC | Device | Class II | 1 |
| 31 Mar 2025 | Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit | AVID Medical, Inc. | Device | Class II | 3 |
| 29 Mar 2025 | Bonya Strawberry Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate . | Knockroe Inc | Food | Class I | 12 |
| 27 Mar 2025 | Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA; | Bausch & Lomb Surgical, Inc. | Device | Class I | 2 |
| 27 Mar 2025 | GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups. | Galt Medical Corporation | Device | Class II | 7 |
| 26 Mar 2025 | The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is ideal for general and specialty… Event 96736 | Trimble Ab | Device | Class II | 1 |
| 24 Mar 2025 | IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application. | Boston Scientific Corporation | Device | Class II | 4 |
| 24 Mar 2025 | Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 24 Mar 2025 | Enterprise 1.5T, Model Number: 781145; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 14 |
| 21 Mar 2025 | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems | GE Medical Systems China Co., Ltd. | Device | Class I | 15 |
| 20 Mar 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control… | Beckman Coulter Inc. | Device | Class II | 1 |
| 19 Mar 2025 | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n. | Siemens Healthcare Diagnostics Inc | Device | Class II | 2 |
| 19 Mar 2025 | Medline Sterile Water, USP, 100mL, REF RDI30295 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 10 |
| 19 Mar 2025 | Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population… | Spectrum Medical Ltd. | Device | Class II | 2 |
| 18 Mar 2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language) | Defibtech, LLC | Device | Class II | 1 |
| 18 Mar 2025 | Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language) | Defibtech, LLC | Device | Class II | 4 |
| 18 Mar 2025 | META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 | Smith & Nephew, Inc. | Device | Class II | 1 |
| 17 Mar 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with… | Beckman Coulter Inc. | Device | Class II | 1 |
| 5 Mar 2025 | HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 | Advanced Bionics, LLC | Device | Class II | 1 |
| 5 Mar 2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, Laboratoire Dermatologique, CAI 86270, La Roche-Posay, France, UPC 883140500759. | L'Oreal USA | Drug | Class II | 3 |
| 4 Mar 2025 | Dinstuhl's Cashew Crunch, NET WT 4 oz. (113g), individually packaged in cellophane bags; Ingredients: Sugar, Cashews, Coconut, Corn Syrup, Brown Sugar, Butter, Salt, Baking Soda. | Dinstuhl's Fine Candy Company, Inc. | Food | Class II | 3 |
| 12 Jul 2024 | Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial… | Meddev Corp | Device | Class II | 2 |
| 21 Feb 2018 | True 3D Viewer, Model: EP-00003 Event 96674 | Echopixel, Inc. | Device | Class II | 1 |
| 11 Apr 2016 | TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a… Event 96629 | Echopixel, Inc. | Device | Class II | 1 |