96 results
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20ms
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Sources: EU EUDAMED, US FDA
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Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS
FDA Recall
Open, Classified
·Alcon Research, LLC·Product code LRO·June 9, 2022
Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, DC 20006, Manufactured by: Medimop Medical Projects Ltd, for OMRIX biopharmaceuticals, Utd, MDA blood bank, Sheba Hospital, Romat-Gan, PO8 888, Kiryat Ono 55000 Israel
FDA Recall
Terminated
·Omrix Biopharmaceuticals, Ltd. Plasma Fract. Inst. Magen David Adom Blood Services Ctr., Sheba Hospital Ramat Gan Israel·Product code FMF·August 6, 2004
Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.
FDA Recall
Terminated
·McKesson Provider Technologies Medical Imaging Group·Product code DQK·January 27, 2010
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.
FDA Recall
Terminated
·Ethicon, Inc. US·Product code FMF·July 2, 2012
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
FDA Recall
Open, Classified
·ETHICON, INC. Calle Durango 2751 Col. Parque Industrial Americas, Juarez Juarez Mexico·Product code GAN·October 8, 2024
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
FDA Recall
Open, Classified
·Ethicon, Inc.·Product code GAN·May 10, 2024
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
FDA Recall
Terminated
·LABSTYLE INNOVATIONS 7, Derekh Menakhem Begin Ramat Gan Israel·Product code NBW·August 29, 2019
ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1 ,an accessory used with the TissueLink BiPolar Floating Device
FDA Recall
Terminated
·Product code GEI·July 22, 2004
ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the TissueLink Bipolar Floating Device
FDA Recall
Terminated
·Product code GEI·July 22, 2004
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·March 9, 2026
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
FDA Recall
Open, Classified
·G & H Wire Company·Product code ECI·December 21, 2023
Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone.
FDA Recall
Terminated
·G & H Wire Company·Product code ECI·January 21, 2021
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·March 9, 2026
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
FDA Recall
Terminated
·Elekta, Inc.·Product code MUJ·November 25, 2013
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
FDA Recall
Open, Classified
·Maquet Cardiopulmonary Gmbh Kehler Str. 31 Rastatt Germany·Product code KRI·June 27, 2025
Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JGJ·September 30, 2015
GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300). The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mounted to a GCX compatible mount or "arm" and provide a data connection to an authorized manufacturer's patient monitoring systems.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code CGA·August 20, 2010
BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
FDA Recall
Open, Classified
·Maquet Medical Systems USA·Product code DTZ·May 18, 2023
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
FDA Recall
Open, Classified
·Maquet Medical Systems USA·Product code DTR·May 18, 2023
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895
FDA Recall
Open, Classified
·Maquet Medical Systems USA·Product code DTZ·May 18, 2023