BEUDAMED
    52 results · 15ms · Sources: EU EUDAMED, US FDA

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    Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code GWG·August 27, 2019

    Karl Storz, Model # 11161C2, Flexible Neuroscope

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code GWG·August 27, 2019

    Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code GWG·August 27, 2019

    Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

    FDA Recall
    Terminated ·Sekisui Diagnostics P.E.I. Inc.·Product code JIF·November 29, 2016

    SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code LEJ·July 8, 2005

    JK Bariatric Beds, True Air Technologies, Inc.

    FDA Recall
    Terminated ·SCM True Air Technologies LLC·Product code OSI·March 18, 2014

    ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code HNQ·December 3, 2024

    Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011

    SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code LEJ·July 25, 2014

    BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code 000·May 7, 2012

    Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FJK·December 10, 2007

    Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.

    FDA Recall
    Terminated ·Gambro Renal Products, Inc.·Product code FJK·May 2, 2008

    Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

    FDA Recall
    Terminated ·Volk Optical Inc·Product code HJK·February 27, 2015

    SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

    STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

    Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A

    FDA Recall
    Open, Classified ·B BRAUN MEDICAL INC·Product code FJK·September 30, 2025

    Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FJK·November 19, 2010

    STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

    STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

    26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FJK·August 31, 2020