FDA Medical Devices

Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnos…

Angel Medical Systems, Inc.

Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests,…

HF Acquisition Co LLC

Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KI…

Cardinal Health 200, LLC

Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D …

Cardinal Health 200, LLC

Critical Feb 19, 2025

Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during …

Getinge Usa Sales Inc

Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1…

Exactech, Inc.

Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2…

Cardinal Health 200, LLC

UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications wi…

Medicrea International

Azurion 3 M12 System Code: (1) 722063 (2) 722221

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).

LivaNova USA, Inc.

Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

New Medical Technologies Gmbh

PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/o…

Ethicon, LLC

IntelliVue Patient Monitor MX400. Model Number: 866060

Philips North America Llc

Optima XR646 HD. X-Ray imaging system.

GE Medical Systems, LLC

IntelliVue Patient Monitor MX450. Model Number: 866062

Philips North America Llc

SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).

LivaNova USA, Inc.

IntelliVue Patient Monitor MX550. Model Number: 866066

Philips North America Llc

Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.

GE Medical Systems, LLC

The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (…

Hologic, Inc.

Critical Feb 12, 2025

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

ROi CPS LLC

Critical Feb 12, 2025

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled adm…

Fresenius Kabi USA, LLC

Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

Oxoid Limited

IntelliVue Patient Monitor MX500. Model Number: 866064

Philips North America Llc

Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Allura CV20 System Code: 722031

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US

Ethicon, LLC

Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Discovery XR656 HD. X-Ray imaging system.

GE Medical Systems, LLC

Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK …

US Endodontics, LLC

AlluraXperFD20/10 System Code: (1) 722029

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

Beckman Coulter, Inc.

Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

AlluraXperFD20/15 System Code: (1) 722058

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

Beckman Coulter Inc.

Azurion 5 M12 System Code: (1) 722227 (2) 722231

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

New Medical Technologies Gmbh

Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740

Boston Scientific Corporation

KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy

KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123

Karl Storz Endoscopy

Critical Feb 5, 2025

Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690

MEDLINE INDUSTRIES, LP - Northfield

KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE

Karl Storz Endoscopy

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

Boston Scientific Corporation

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560

Boston Scientific Corporation