BEUDAMED
    20 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·June 30, 2021

    Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·June 30, 2021

    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.

    FDA Enforcement
    Class II ·Terminated·Ormco/Sybronendo·December 9, 2015

    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.

    FDA Enforcement
    Class II ·Terminated·SALTER LABS·July 4, 2012

    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.

    FDA Enforcement
    Class II ·Terminated·Salter Labs·July 30, 2014

    NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.

    FDA Enforcement
    Class II ·Terminated·Salter Labs·September 23, 2015

    Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.

    FDA Enforcement
    Class II ·Terminated·SALTER LABS·November 27, 2013

    T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.

    FDA Enforcement
    Class II ·Terminated·Salter Labs·February 17, 2016

    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·March 21, 2018

    Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.

    FDA Enforcement
    Class II ·Terminated·Wexford Labs Inc·November 27, 2013

    Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.

    FDA Enforcement
    Class II ·Terminated·Lab Vision Corporation·January 22, 2014

    miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.

    FDA Enforcement
    Class II ·Terminated·Miramar Labs, Inc.·November 18, 2015

    AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Ansh Labs, LLC·January 20, 2021

    Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients.

    FDA Enforcement
    Class II ·Terminated·Heritage Labs International LLC·April 24, 2013

    Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    FDA Enforcement
    Class II ·Terminated·Hand Biomechanics Lab Inc·October 26, 2016

    Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH CARE-72 DSE ENDO 14FR; c. HALYARD* TRACH CARE-72 WET PAK* 14FR; d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR; e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN); f. HALYARD* TRACH CARE-72 DSE TRACH 14FR; g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR; h. HALYARD* TRACH CARE-72 DSE ENDO 10FR; i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK); j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR; k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR; l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR; n. HALYARD* 72 DSE TRACH CARE 12FR; o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN); p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN); r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR; u. HALYARD* TC-72 WET PAK DSE 14FR; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE); x. HALYARD* TRACH CARE-72 DSE ENDO 12FR; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); z. HALYARD* TRACH CARE-72 DSE TRACH 12FR; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE); ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR; ai. HALYARD* TRACH CARE-72 DSE 16FR; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); al. HALYARD* TURBO-CLEANING 14FR DSE Endo;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.

    FDA Enforcement
    Class II ·Terminated·LAP of America Laser Applications, LLC·June 11, 2014

    LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.

    FDA Enforcement
    Class II ·Terminated·LAP of America Laser Applications, LLC·July 2, 2014

    Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ55107A BODY PACK DYNJ55107C BODY PACK DYNJ55107D C SECTION CDS CDS984613D C SECTION CDS CDS830172I C SECTION CDS CDS984613F C SECTION CDS CDS830172J C SECTION PACK CMPJ17294I C SECTION PACK-LF DYNJ64834 CARDIAC A & B SJ PACK DYNJ0619768D CARDIAC PROCEDURE PACK DYNJ63700 CLOSURE CDS CDS983704D CLOSURE CDS CDS983704F CLOSURE CDS CDS983704G COLECTOMY LAPAROSCOPIC DYNJ906875 COLORECTAL ME DYNJ906437 CRANIOTOMY DYNJ905330A CRANIOTOMY DYNJ905330B C-SECTION PACK DYNJ32884F C-SECTION PACK DYNJ32884G C-SECTION PACK DYNJ32884I C-SECTION PACK DYNJ32884J C-SECTION TRAY DYNJ62707 CYSTO DYNJ901329B CYSTO DYNJ901608B CYSTO DYNJ903225I CYSTO CDS982015O CYSTO DYNJ903225J CYSTO CDS982015P CYSTO DYNJ903225K CYSTO DYNJ906481 CYSTO DYNJ903225L CYSTO CDS CDS985376C CYSTO CDS-LF CDS982481I CYSTO CDS-LF CDS982481J CYSTO CDS-LF CDS982481K CYSTO CDS-LF CDS982481L CYSTO PACK DYNJ05177G CYSTO PACK DYNJ51350A CYSTO PACK DYNJ37252F CYSTO PACK DYNJV0052L CYSTO PACK DYNJ37680D CYSTO PACK DYNJ58223 CYSTO PACK DYNJ53570A CYSTO PACK CMPJ01845I CYSTO PACK DYNJ37252G CYSTO PACK DYNJ37252I CYSTO PACK-LF DYNJ24911D CYSTO PACK-LF CMPJ02168J CYSTO PACK-LF DYNJ30470B CYSTO PACK-LF CMPJ02168K CYSTO PACK-LF DYNJ51350B CYSTO PACK-LF DYNJ51350C CYSTO TRAY-LF DYNJ42146A CYSTO/UROLOGY PACK DYNJ64197 CYSTO-LF DYNJ50098 CYSTOSCOPY-LF DYNJ22891I D&C HYSTEROSCOPY DYNJ901049B D&C HYSTEROSCOPY DYNJ901049C D&C HYSTEROSCOPY DYNJ901049D D&C HYSTEROSCOPY PACK CMPJ43148C D&C HYSTEROSCOPY PACK CMPJ43148D D&C HYSTEROSCOPY PACK CMPJ43148F D&C PACK DYNJ33603D D&C PACK DYNJ22567C D&C PACK DYNJ22567D D&C PACK DYNJ55814B D&C PACK-LF DYNJ22567F D&C/GYN-LF DYNJ61949 D&C/GYN-LF DYNJ61949A D&C-LF DYNJ50099A D&C-LF DYNJ906482 DELIVERY PACK SMMC-LF DYNJ35244D DELIVERY PACK SMMC-LF DYNJ35244F DENTAL ENT PACK-LF DYNJ43405B DR H PACK DYNJ62374 DR. S PACK DYNJ60499 EAR DYNJ906058A EAR DYNJ906058B EAR DYNJ906058F GEN PLASTIC DYNJ901298A GENERAL DELIVERY PACK-LF DYNJ15915F GENERAL PACK DYNJ37894B GENERAL PACK DYNJ61784 G S CYSTO PACK DYNJ62403 G CYSTO CDS CDS984190G G CYSTO CDS CDS984190I G CYSTO CDS CDS984190J G D & C CDS CDS984203F G D & C CDS CDS984203G G D & C CDS CDS984203I G D & C CDS CDS984203J G LASER VEIN CDS CDS984193M G LASER VEIN CDS CDS984193N G PELVISCOPY CDS CDS984187M G PELVISCOPY CDS CDS984187N G PELVISCOPY CDS CDS984187O G PELVISCOPY CDS CDS984187P G VAGINAL CDS CDS984201M G VAGINAL CDS CDS984201O G VAGINAL CDS CDS984201P G VAGINAL CDS CDS984201Q GU SEED PACK-RF-LF DYNJ01631F GU-GEN ROBOTIC PACK CMPJ11121 GYN LAPAROSCOPY DYNJ903869 GYN LAPAROSCOPY DYNJ901636B GYN LAPAROSCOPY DYNJ902101A GYN LAPAROSCOPY DYNJ37256D GYN LAPAROSCOPY DYNJ903869A GYN LAPAROSCOPY DYNJ903869B GYN LAPAROSCOPY DYNJ903869C GYN LAPAROSCOPY DYNJ903869D GYN LAPAROSCOPY CDS CDS983410C GYN LAPAROSCOPY CDS CDS985217D GYN LAPAROSCOPY CDS CDS983410D GYN LAPAROSCOPY CDS CDS985217F GYN LAPAROSCOPY CDS CDS983410F GYN LAPAROSCOPY CDS CDS985217G GYN LAPAROSCOPY PACK DYNJ48614C GYN LAPAROSCOPY PACK DYNJ22568F GYN LAPAROSCOPY PACK DYNJ22568G GYN LAPAROSCOPY PACK DYNJ37337G GYN LAPAROSCOPY PACK-LF DYNJ22568I GYN LAPAROSCOPY/LAVH CDS CDS981294C GYN LITHOTOMY PACK DYNJ48615B GYN ONCOLOGY ME DYNJ900201G GYN ROBOTIC DYNJ903282D GYN ROBOTIC DYNJ903282F GYN ROBOTIC DYNJ903282G GYN ROBOTIC DYNJ903282I GYN ROBOTIC DYNJ903282J GYN ROBOTIC DYNJ903282L GYN-URO LAPAROSCOPY DYNJ904856 GYN-URO LAPAROSCOPY DYNJ904856A HEAD AND NECK PACK DYNJ46509C HEART PACK A&B CMPJ22236V HH PAIN CLINIC PACK DYNJ59488 HMT CY

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·May 27, 2020