42 results
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11ms
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Sources: EU EUDAMED, US FDA
Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.
FDA Enforcement
Class III
·Terminated·Diagnostic Hybrids Inc·February 13, 2013
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
FDA Enforcement
Class III
·Terminated·Arc Medical Inc·May 20, 2015
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
FDA Enforcement
Class III
·Terminated·Pega Medical Inc.·May 27, 2020
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD Inc.·October 10, 2018
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD Inc.·October 10, 2018
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD Inc.·October 10, 2018
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD Inc.·October 10, 2018
smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD Inc.·October 10, 2018
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
FDA Enforcement
Class III
·Terminated·St Jude Medical Inc·January 9, 2013
AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
FDA Enforcement
Class III
·Terminated·Applied Medical Technology Inc·March 1, 2017
Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD, Inc.·February 4, 2015
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD, Inc.·February 15, 2017
AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
FDA Enforcement
Class III
·Terminated·Applied Medical Technology Inc·March 1, 2017
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD Inc.·September 26, 2018
Neoprobe GDS Control Unit, Model Number NPCU3
FDA Enforcement
Class III
·Terminated·Devicor Medical Products Inc·October 14, 2020
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD Inc.·November 3, 2021
AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
FDA Enforcement
Class III
·Terminated·Applied Medical Technology Inc·December 30, 2020
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology.
FDA Enforcement
Class III
·Terminated·Siemens Medical Solutions USA, Inc·August 24, 2022
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·September 26, 2012
Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.
FDA Enforcement
Class III
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 3, 2021