20 results · 14ms · Sources: EU EUDAMED, US FDA

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Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·July 1, 2009

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

Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

FDA Recall
Terminated ·Maquet Medical Systems USA·Product code FSY·April 16, 2014

Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.

FDA Recall
Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code DQY·April 1, 2014

Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.

FDA Recall
Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code DQY·April 1, 2014

Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121

FDA Recall
Terminated ·Gen-Probe Inc·Product code MDK·May 2, 2007

Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.

FDA Recall
Terminated ·Gen-Probe Inc·Product code LQF·December 30, 2008

Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.

FDA Recall
Terminated ·Gen-Probe Inc·Product code MDK·December 30, 2008

Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.

FDA Recall
Terminated ·Gen-Probe Inc·Product code LQF·December 30, 2008

Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,

FDA Recall
Terminated ·Gen Probe Inc·Product code NDZ·June 11, 2004

APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.

FDA Recall
Terminated ·Gen-Probe Inc·Product code OIE·April 17, 2014

Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed. Intended use: Soft Tissue approximation.

FDA Recall
Terminated ·Ethicon, Inc. US·Product code GAM·April 20, 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

Integra Container Lid, Size, Red; Container Lid, Size, Blue; Container Lid, Size, Red; Container Lid, Size, Gold; Container Lid, Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.

FDA Recall
Terminated ·Integra York PA, Inc·Product code KCT·July 30, 2014

VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea (UREA), in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code CDN·June 12, 2013

Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code GBN·October 8, 2014

VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.

FDA Recall
Terminated ·Siemens Medical Solutions Diagnostics·Product code LXG·April 25, 2014

Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DWC·November 13, 2015

Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HAW·May 4, 2015

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