FDA Medical Devices

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

Randox Laboratories, Limited

BD Pyxis MedStation 4000 Main, REF 303

CareFusion 303, Inc.

Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) …

St. Jude Medical

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Nu…

Olympus Corporation of the Americas

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-05…

Olympus Corporation of the Americas

Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;

Adept Medical Ltd

Bodor P and C series laser cutting machines

Jinan Bodor Cnc Machine Co Ltd

BD Pyxis Med 4000 Auxiliary (AUX), REF 314

CareFusion 303, Inc.

BD Pyxis MedStation ES (Med ES Main), REF 323

CareFusion 303, Inc.

CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pre…

Integra LifeSciences Corp.

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

Randox Laboratories, Limited

Baxter Solution Set with Duo-Vent Spike, REF 2R8404

Baxter Healthcare Corporation

Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538

Baxter Healthcare Corporation

Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

Adept Medical Ltd

EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)

Medtronic Perfusion Systems

BD Pyxis MedStation 4000 AUX, REF 306

CareFusion 303, Inc.

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model N…

Boston Scientific Corporation

Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

Baxter Healthcare Corporation

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-…

Augustine Temperature Management, LLC

8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401

Intuitive Surgical, Inc.

X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB632…

Coloplast Manufacturing US, LLC

8MM,MEGA SUTURECUT ND,IS4000 REF 471309

Intuitive Surgical, Inc.

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DIL…

Sklar Instruments

8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006

Intuitive Surgical, Inc.

8MM,PROGRASP FORCEPS,IS4000 REF 471093

Intuitive Surgical, Inc.

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAU…

Sklar Instruments

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the inst…

Olympus Corporation of the Americas

Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

Cook Biotech, Inc.

Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

Hologic, Inc.

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refu…

Augustine Temperature Management, LLC

Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

SIN SISTEMA DE IMPLANTE NACIONAL S.A

ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical

Sklar Instruments

8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179

Intuitive Surgical, Inc.

Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP…

Sklar Instruments

8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246

Intuitive Surgical, Inc.

Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNED…

MEDLINE INDUSTRIES, LP - Northfield

8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205

Intuitive Surgical, Inc.

Impella RP Flex with SmartAssist; Product Number: 1000323;

Abiomed, Inc.

8MM,LONG TIP FORCEPS,IS4000 REF 471048

Intuitive Surgical, Inc.

nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquade…

Nuwellis Inc

Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK …

Cardinal Health 200, LLC

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK …

Sklar Instruments

8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033

Intuitive Surgical, Inc.

Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery c…

Alcon Research LLC

GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)

Sklar Instruments

GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N …

Cardinal Health 200, LLC