34 results
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23ms
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Sources: EU EUDAMED, US FDA
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
FDA Enforcement
Class II
·Ongoing·Skytron, Div. The KMW Group, Inc·July 6, 2022
Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 17, 2024
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
FDA Enforcement
Class II
·Ongoing·Remel, Inc·February 26, 2025
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
FDA Enforcement
Class II
·Ongoing·Remel, Inc·February 26, 2025
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
FDA Enforcement
Class II
·Ongoing·Remel, Inc·July 5, 2023
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
FDA Enforcement
Class II
·Ongoing·Human Care Hc Sweden Ab·April 17, 2024
Hanger-Bar 2P 45cm
FDA Enforcement
Class II
·Ongoing·Human Care USA, Inc.·April 6, 2022
Hanger-Bar 2P 45cm
FDA Enforcement
Class II
·Ongoing·Human Care USA, Inc.·April 6, 2022
Strep Selective II Agar, Product Number R01859
FDA Enforcement
Class II
·Ongoing·Remel, Inc·August 6, 2025
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
FDA Enforcement
Class II
·Ongoing·Remel, Inc·August 6, 2025
BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
FDA Enforcement
Class II
·Ongoing·Intrinsic Therapeutics, Inc.·August 28, 2024
PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021
FDA Enforcement
Class II
·Ongoing·Moller Vital·May 22, 2019
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 21, 2022
Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
FDA Enforcement
Class II
·Ongoing·Moller Vital·May 22, 2019
Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 17, 2024
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·December 27, 2023
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
FDA Enforcement
Class II
·Ongoing·PHASE SCIENTIFIC INTERNATIONAL LIMITED·January 24, 2024
BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024