143 results
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18ms
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Sources: EU EUDAMED, US FDA
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Recall
Terminated
·Product code FPA·November 7, 2014
Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP). Smiths Medical MD, Inc., St. Paul, MN 55112 USA; RX ONLY.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FRN·January 19, 2007
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
FDA Recall
Terminated
·Greiner Bio-One North America, Inc.·Product code JKA·December 9, 2021
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
FDA Recall
Terminated
·Abbott·Product code NIK·February 28, 2020
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
FDA Recall
Terminated
·St Jude Medical Inc.·Product code NIK·August 28, 2017
VACUETTE Cellestis 1 ml QuantiFERON - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
FDA Recall
Terminated
·Cellestis Inc·Product code NCD·September 27, 2012
St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
FDA Recall
Terminated
·St Jude Medical CRMD·Product code KRG·October 6, 2006
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
FDA Recall
Terminated
·St Jude Medical Inc.·Product code OSR·April 16, 2018
Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.
FDA Recall
Terminated
·St Jude Medical Inc.·Product code MXC·April 16, 2018
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
FDA Recall
Terminated
·Cook Inc.·Product code PYC·April 9, 2019
Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
FDA Recall
Terminated
·Cochlear Americas Inc.·Product code LXB·December 18, 2018
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, elec- tron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code MUJ·December 26, 2018
Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
FDA Recall
Terminated
·Deltec, Inc·Product code FRN·June 23, 2003
VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufactured by: Greiner bio-one NA, Inc., 4238 Capital Drive, Monroe, NC 28110. The Greiner Vacuette blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.
FDA Recall
Terminated
·Greiner Bio-One North America, Inc.·Product code JKA·July 29, 2008
Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
FDA Recall
Terminated
·Krishe Inc·Product code QBD·March 11, 2021
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
FDA Recall
Terminated
·Cook Inc.·Product code GBX·March 6, 2020
Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile.
FDA Recall
Terminated
·Greiner VACUETTE North America·Product code GIM·July 27, 2004
Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile * manufactured by: Greiner Bio-one North America, Inc., 4238 Capital Drive, Monroe, NC 28110, USA
FDA Recall
Terminated
·Greiner Bio-One North America, Inc.·Product code GIM·August 2, 2006
Disposable Tips 1000 l with filter Conductive disposable tips for Tecan Genesis Series * Order Number 612513.1 * Tecan Schweiz AG Seestrae 103, CH-8708 Mannedorf, Switzerland * Made in Germany. Blister 1 x 96 pcs.
FDA Recall
Terminated
·Tecan U S Inc·Product code JQW·April 11, 2005
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code KWD·November 6, 2014