11 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320
FDA Enforcement
Class II
·Terminated·Flexicare Medical Ltd.·January 22, 2020
BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.
FDA Enforcement
Class II
·Terminated·Flexicare Medical Ltd.·January 22, 2020
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.
FDA Enforcement
Class II
·Terminated·Flexicare Medical Ltd.·January 22, 2020
INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
FDA Enforcement
Class II
·Terminated·Ace Surgical Supply Co., Inc.·April 26, 2017
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
FDA Enforcement
Class II
·Terminated·Ace Surgical Supply Co., Inc.·May 2, 2018
NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
FDA Enforcement
Class II
·Ongoing·Ace Surgical Supply Co., Inc.·March 30, 2022
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·March 27, 2024
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·March 27, 2024
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·January 24, 2024
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·January 24, 2024
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