BEUDAMED
    34 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FBN·August 31, 2020

    BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Recall
    Terminated ·BIOTRONIK Inc·Product code MRM·March 8, 2021

    BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Recall
    Terminated ·BIOTRONIK Inc·Product code LWS·March 8, 2021

    Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code NBC·April 5, 2012

    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NCF·June 30, 2017

    ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NCF·June 30, 2017

    STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.

    FDA Recall
    Terminated ·HF Acquisition Co. LLC·Product code LRR·June 5, 2020

    STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQI·February 24, 2016

    Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ITW·February 24, 2016

    Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code KQZ·March 14, 2016

    Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code KQZ·March 14, 2016

    Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IPY·February 24, 2016

    Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code KQZ·March 14, 2016

    NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·February 24, 2016

    The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·February 26, 2015

    Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·February 24, 2016