9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·January 30, 2012
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 Recall
Terminated
·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code OGH·November 27, 2019
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 Recall
Terminated
·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code CCW·November 27, 2019
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
Calcium Sulfate Hemihydrate 1.0 gram kits.
FDA Recall
Terminated
·Ace Surgical Supply Co., Inc.·Product code LYC·May 14, 2010
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
FDA Recall
Terminated
·Ace Surgical Supply Co., Inc.·Product code EMO·March 28, 2018
Calcium Sulfate Hemihydrate 0.5 gram kits.
FDA Recall
Terminated
·Ace Surgical Supply Co., Inc.·Product code LYC·May 14, 2010
INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
FDA Recall
Terminated
·Ace Surgical Supply Co., Inc.·Product code DZE·February 22, 2017