Z-0309-2027Pentax of America IncPENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.
Class IIOngoing
Nov 4, 2026Report Date
D-0081-2027Prodose, Inc.ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, Distributed by:Prodose, Inc. Ronkonkoma, NY 11779, Made in India. UPC 8 50026 88900 0
Class IIIOngoing
Nov 4, 2026Report Date
D-0106-2027Eagle Pharma Outsourcing LLCOXYTOCIN, 30 USP UNITS, Added to 0.9% Sodium Chloride 500 mL - Single-Use Container, Rx Only, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL 35244, UPC: 6985203050. NDC 69852-030-50
Class IIOngoing
Nov 4, 2026Report Date
Z-0208-2027Abiomed, Inc.Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
Class IOngoing
Nov 4, 2026Report Date
Z-0299-2027PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
Class IIOngoing
Nov 4, 2026Report Date
D-0095-2027ABC Compounding Co., Inc.Handtastic Foamy Mango Antiseptic Foam Soap Hand & Body Wash, Net Contents : 18oz (532ml), Sold by, Momar Incorporated, 1880 Ellsworth Industrial Drive, N.W., Atlanta, Georgia, 80818.
Class IIOngoing
Nov 4, 2026Report Date
Z-0291-2027Canon Medical System, USA, INC.ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V
Class IIOngoing
Nov 4, 2026Report Date
Z-0294-2027PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Philips Azurion 5 M12. Model Number: 722227.
Class IIOngoing
Nov 4, 2026Report Date
D-0094-2027ABC Compounding Co., Inc.Lynx, antibacterial hand soap, Refill, Net Contents 1 Gallon, (3.8 L), Manufactured by: ABC Compounding Co., INC., 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808200027.
Class IIOngoing
Nov 4, 2026Report Date
Z-0290-2027Canon Medical System, USA, INC.ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
Class IIOngoing
Nov 4, 2026Report Date
D-0091-2027ABC Compounding Co., Inc.Antiseptic Hand Soap, Net Contents: 1 Gallon (3.8 L) Distributed By: image supply, inc., P.O. Box 1108, 5081 Dawn Drive, Lumberton, NC28359
Class IIOngoing
Nov 4, 2026Report Date
D-0088-2027ABC Compounding Co., Inc.Certus Medical Satin Foam, 750 ml (25.4 fl. oz.), Manufactured for: Cartus Medical, 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808250930
Class IIOngoing
Nov 4, 2026Report Date
Z-0286-2027ZIEHM-ORTHOSCAN INCOrthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Class IIOngoing
Nov 4, 2026Report Date
Z-0285-2027Medtronic, Inc.OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with an RV defibrillation coil electrode. The lead is designed for pacing, sensing, cardioversion, and defibrillation therapies.
Class IIOngoing
Nov 4, 2026Report Date
Z-0295-2027PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Philips Azurion 5 M20. Model Numbers: 722228, 722281.