49 results
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9ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
FDA Enforcement
Class II
·Terminated·Synvasive Technology Inc·April 24, 2013
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
FDA Enforcement
Class II
·Terminated·EKOS Corporation·September 28, 2016
EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries.
FDA Enforcement
Class II
·Terminated·EKOS Corporation·July 25, 2012
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
FDA Enforcement
Class II
·Terminated·EKOS Corporation·July 29, 2015
The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.
FDA Enforcement
Class II
·Terminated·EKOS Corporation·October 5, 2016
The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
FDA Enforcement
Class II
·Terminated·EKOS Corporation·November 13, 2013
EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
FDA Enforcement
Class II
·Terminated·EKOS Corporation·March 2, 2016
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·July 5, 2017
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
HAND PACK-Procedure Kit Catalog Number: WEHD16C
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024