16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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gammaCore Sapphire
FDA 510(k)
FDA Class 2
·Neurology
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074465449·CDH HA COATED MAS 8.5X30
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741918300·
CHUCK HANDLE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075207·CHUCK HANDLE ROUND
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180543627·30mm Cervical Tooth Blade, Wide
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674191830060·
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO
FDA 510(k)
FDA Class 2
·Cardiovascular
ZMACHINE, MODEL DT-100
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
ACCENT DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 26, 2013
IDRIVE POWERED HANDLE
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code GDW·July 29, 2011
Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts and wounds.
FDA Enforcement
Class II
·Terminated·ASO, LLC·August 14, 2013
Neusoft NeuViz 64 Multi-slice CT Scanner System
FDA Recall
Terminated
·Neusoft Medical System Co·Product code JAK·March 8, 2014
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024