428 results
·
20ms
·
Sources: EU EUDAMED, US FDA
AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
FDA Recall
Terminated
·Fenwal Inc·Product code LKN·May 24, 2013
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code KDJ·October 6, 2015
GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code FER·December 12, 2018
Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
FDA Recall
Terminated
·Atrium Medical Corporation·Product code CAC·November 8, 2006
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
FDA Recall
Terminated
·Microport Orthopedics INC.·Product code LXH·April 30, 2014
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code FKX·October 10, 2018
Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 371 3, Manufactured for Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KPE·July 27, 2017
Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the cement during delivery.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code KIH·January 13, 2012
ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.
FDA Recall
Terminated
·AGFA Corp.·Product code KPR·November 18, 2005
Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL, Order No. REF 706, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile and non-pyrogenic in unopened, undamaged package, 250 mL, Order No. REF: 706D, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code CGJ·November 5, 2012
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
FDA Recall
Terminated
·ConMed Corporation·Product code GEI·May 8, 2014
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
FDA Recall
Terminated
·Baxter Healthcare Corp·Product code KPE·September 16, 2014
Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code CAC·November 19, 2013
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
FDA Recall
Terminated
·Baxter Healthcare Corp·Product code KPE·September 16, 2014
Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FMG·November 19, 2018
STAT 2 Pumpette I.V. Compensating Controller, Catalog/REF No. PS2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.
FDA Recall
Terminated
·ConMed Corporation·Product code LDR·April 15, 2011
Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Remington Medical, Inc., Alpharetta, GA 30005.
FDA Recall
Terminated
·Remington Medical Inc.·Product code EXF·July 23, 2007