FDA Medical Devices

Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;

Siemens Healthcare Diagnostics, Inc.

Low Nov 19, 2025

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laborato…

Accriva Diagnostics, Inc.

Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

Abbott Medical

Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of labo…

TECHNO-PATH MANUFACTURING LTD.

Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400

Abbott Medical

Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical…

Medline Industries, LP

Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms

GE Healthcare Finland Oy

Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MA…

Medline Industries, LP

DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF

Medline Industries, LP

Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I

Applied Medical Technology Inc

Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I

Applied Medical Technology Inc

Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;

Covidien, LP

Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Numb…

Olympus Corporation of the Americas

Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D

Medline Industries, LP

Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I

Applied Medical Technology Inc

3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2U…

Siemens Healthcare Diagnostics, Inc.

Convenience Kit, BREAST HERNIA DYNJ909125G

Medline Industries, LP

ProxiDiagnost N90; Model Number: 706110;

Philips Medical Systems DMC GmbH

Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and …

Abbott Laboratories

Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical,…

Medline Industries, LP

BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revisi…

GE Healthcare Finland Oy

Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ9091…

Medline Industries, LP

IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;

Siemens Healthcare Diagnostics, Inc.

CombiDiagnost R90; Model Number: 709031;

Philips Medical Systems DMC GmbH

Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING

Medline Industries, LP

Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-C…

Prismatik Dentalcraft, Inc.

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;

Mozarc Medical US LLC

Critical Nov 12, 2025

CODMAN Disposable Perforator 11mm. Cranial Perforator.

Integra LifeSciences Corp. (NeuroSciences)

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;

Mozarc Medical US LLC

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

B-K Medical A/S

Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.

OSSTEM Implant Co., Ltd.

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi…

Zimmer, Inc.

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

B-K Medical A/S

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;

Mozarc Medical US LLC

Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

Beckman Coulter, Inc.

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

B-K Medical A/S

Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

OSSTEM Implant Co., Ltd.

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi…

Zimmer, Inc.

Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head…

Total Joint Orthopedics, Inc.

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex F…

B-K Medical A/S

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;

Mozarc Medical US LLC

bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

B-K Medical A/S

Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

OSSTEM Implant Co., Ltd.

Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Informat…

Spacelabs Healthcare, Ltd.

Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

Alcon Research LLC

Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;

PHILIPS MEDICAL SYSTEMS

Critical Nov 5, 2025

IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

IMPRIS Imaging Inc

Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;

DAYE (ANNE'S DAY LTD)

ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

ICU Medical, Inc.