FDA Medical Devices

Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

Philips North America Llc

Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinna…

ORTOMA AB

Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. …

Philips North America Llc

Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.

Philips North America Llc

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer t…

CooperVision, Inc.

Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

Philips North America Llc

Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. …

Philips North America Llc

Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080

Biomet, Inc.

FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmA…

Biofire Defense

Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA0…

Mindray DS USA, Inc. dba Mindray North America

Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728…

Philips North America Llc

Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone…

CooperVision, Inc.

Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3…

Philips North America Llc

Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

Boston Scientific Corporation

Critical Oct 1, 2025

Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532…

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not app…

Agilent Technologies Denmark ApS

i-STAT EG6+ cartridge. List Number: 03P77-25.

Abbott Point Of Care Inc.

3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370

3M Company

Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

Folsom Metal Products, Inc.

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist componen…

Max Mobility LLC

Heartstring III Proximal Seal System. Intravascular anastomosis occluder.

Maquet Cardiovascular, LLC

Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile

Folsom Metal Products, Inc.

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC

The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm r…

BigTree Sales Inc.

i-STAT CG4+ cartridge (white). List Number: 03P85-25.

Abbott Point Of Care Inc.

UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

Beckman Coulter Inc.

SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

C.R. Bard Inc

SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A

C.R. Bard Inc

Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), RE…

Exactech, Inc.

Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

Boston Scientific Neuromodulation Corporation

Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 …

Philips Medical Systems (Cleveland) Inc

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not ap…

Agilent Technologies Denmark ApS

Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.

Maquet Cardiovascular, LLC

Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile

Folsom Metal Products, Inc.

UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478

Beckman Coulter Inc.

MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

Medical Information Technology, Inc.

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

Abbott Point Of Care Inc.

VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.

Ortho-Clinical Diagnostics, Inc.

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not a…

Agilent Technologies Denmark ApS

UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520

Beckman Coulter Inc.

Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile

Folsom Metal Products, Inc.

UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858

Beckman Coulter Inc.

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC