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Sources: EU EUDAMED, US FDA
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Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
FDA Recall
Terminated
·Zavation·Product code NDN·March 25, 2021
Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
FDA Recall
Terminated
·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010
Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
FDA Recall
Terminated
·Iba Dosimetry·Product code IYE·April 26, 2017
Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures S194 Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
FDA Recall
Terminated
·Product code GAP·June 3, 2011
Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
FDA Recall
Terminated
·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·February 10, 2016
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
FDA Recall
Terminated
·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·February 10, 2016
ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
FDA Recall
Terminated
·Arrow International, Inc.·Product code DSP·February 2, 2009
ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
FDA Recall
Terminated
·Arrow International, Inc.·Product code DSP·February 2, 2009
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
FDA Recall
Terminated
·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·August 20, 2013
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
FDA Recall
Terminated
·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·September 25, 2014
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
FDA Recall
Terminated
·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·December 10, 2015
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
FDA Recall
Terminated
·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·February 2, 2015
myQA iON; Article Number: MQ10-000;
FDA Recall
Open, Classified
·IBA Dosimetry GmbH Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·April 1, 2025
Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 Performing ultrasound guided biopsies of the prostate.
FDA Recall
Terminated
·Bk Medical Mileparken 34 Iierlev Denmark·September 8, 2008
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·November 30, 2023
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025